Visual Performance of Senofilcon A With and Without a New UV/HEV-filter: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Visual Performance of Senofilcon A With and Without a New UV/HEV-filter (NCT05021081), a randomized na study. The primary outcome is Photopic Contrast Sensitivity at 6 Cpd.

2. Clinical Question

That distinction matters when reading the results. The primary result concerns a glare-source assessment in Phase 1, where subjects wore their own contact lenses. The trial title refers to senofilcon A with and without a new UV/HEV filter, but the posted primary endpoint is not a randomized test-versus-control lens outcome. The Phase 2 contrast-sensitivity outcomes are secondary results and are the posted results that directly compare the test and control lenses.

The registry lists 82 participants enrolled overall. The endpoint summaries have their own analysis populations: the primary Phase 1 summaries report 15 subjects, while each posted Phase 2 secondary outcome reports 62 per lens group. The registry record does not explain the relationship between those populations or give a full participant flow. These results therefore answer specific visual-performance questions within the recorded phases and analysis groups; they do not, by themselves, establish how the lenses compare on outcomes not reported in the record.

3. Trial Design

The registry describes a completed, randomized, double-masked study with a parallel model and an enrollment of 82. It lists two phases. Phase 1 was non-randomized, non-masked, and non-dispensing: subjects wore their own contact lenses for approximately 1 hour. Its stated purpose was to evaluate photopic contrast sensitivity with and without a broadband glare source. Phase 2 was described as controlled, randomized, double-masked, contralateral, and non-dispensing, with study lenses worn in a daily-wear modality for approximately 3 hours.

For Phase 2, the registry describes two possible contralateral sequences: test/control and control/test. The primary outcome record instead concerns the Phase 1 glare comparison. The Phase 2 results report test and control Senofilcon A C3 groups for two secondary contrast-sensitivity outcomes. The outcomes were measured at least 5 minutes after lens fitting and up to 2 hours during Phase 2. The record does not detail how the contralateral measurements were incorporated into the posted summary comparisons.

Enrollment is not the same as the number contributing to every endpoint. The primary Phase 1 summaries list 15 subjects in each glare condition, while the Phase 2 secondary summaries list 62 observations for each lens group. The registry record does not report a complete account of screening, exclusions, withdrawals, or missing outcome data that would reconcile these analysis counts with overall enrollment.

The study status is completed. The recorded start date is 2021-08-23 and the primary completion date is 2021-10-20. The record lists no phase designation beyond NA. Details such as the trial's original sample-size justification, any interim analyses, and the full statistical analysis plan are not reported in the registry record. The planned two-sided significance level and equal-allocation assumptions discussed for the sample-size illustration are not identified as the original trial design assumptions.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Phase 1

Phase 2

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All subjects that completed Phase 1 without a major protocol deviation excluding subjects recording an increase in photopic contrast sensitivity with the glare source.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: All subjects enrolled and completed in Phase 1. All subjects dispensed in Phase 2.

6. Primary Endpoint

The registry lists the primary outcome as Photopic Contrast Sensitivity at 6 Cpd, measured over Post screening up to 1 hour during Phase 1.

The primary endpoint is photopic contrast sensitivity at 6 cpd, measured in log units. Photopic describes testing under the stated brighter-light condition, approximately 120 cd/m2. The measurement was taken in the right eye only, first without a broadband glare source and then with glare. The endpoint description says testing used 8 reversals, with the last 4 averaged to provide the contrast threshold.

Contrast sensitivity describes the ability to detect contrast at a specified spatial frequency. The endpoint is used in this study to quantify visual performance under a glare challenge, rather than to record a general measure of eyesight. A lower estimated mean with glare indicates lower contrast sensitivity in this assessment. The protocol description states that a reduction of about 0.1 log units was the approximate criterion for considering the glare source effective and moving to Phase 2. This is a study-progression criterion described in the registry, not a clinical threshold established by these results.

The primary population was subjects who completed Phase 1 without a major protocol deviation, excluding those who recorded an increase in photopic contrast sensitivity with glare. The outcome therefore describes a selected Phase 1 analysis population, not all enrolled participants. The primary endpoint is also distinct from the Phase 2 outcomes, which compare test and control lenses on photopic and mesopic contrast sensitivity with a glare source.

7. Results Posted in the Registry

• Without Glare: mean 1.91 versus 1.46 on control; difference 0.45 (95% CI 0.20 to 0.70), standardized effect d = 1.30; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Photopic Contrast Sensitivity With a Glare Source

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Test (Senofilcon A C3): mean 1.18 versus 1.21 on control; difference -0.03 (95% CI -0.12 to 0.06), standardized effect d = -0.12; z-test p = 0.502.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Test (Senofilcon A C3) and the control. The interval gives the range of effects that remain compatible with the data.

Mesopic Contrast Sensitivity With a Glare Source

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Test (Senofilcon A C3): mean 0.71 versus 0.72 on control; difference -0.01 (95% CI -0.09 to 0.07), standardized effect d = -0.04; z-test p = 0.802.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Test (Senofilcon A C3) and the control. The interval gives the range of effects that remain compatible with the data.

Across the two Phase 2 secondary outcomes, the test and control group means are close in the posted summaries, and both unadjusted confidence intervals include zero. The common pattern is therefore one of little separation in the observed group means, with uncertainty remaining about the range of differences compatible with the data and calculations. These secondary results add context to the study's primary glare assessment, but they answer a different question: they compare test and control lenses during Phase 2 rather than comparing glare with no glare in Phase 1.

The primary outcome found a marked contrast between the with-glare and without-glare Phase 1 measurements in the selected analysis population. The Phase 2 results do not replicate that same contrast, because the comparison, phase, and conditions differ. They should not be combined into a single overall effect or treated as confirmation of the primary result. No direct statistical test linking the Phase 1 and Phase 2 results is reported in the registry record.

These secondary comparisons are unadjusted recalculations, and the registry record does not report a multiplicity procedure. When several outcomes are examined, the chance of at least one apparently notable result can increase if each is judged separately without adjustment. The posted Phase 2 findings are not small p-values, but the broader principle still matters: secondary outcomes generally carry less confirmatory weight when they are not identified as primary, are analyzed without a reported multiplicity strategy, or lack sponsor-reported design-adjusted results.

The registry lists two secondary contrast-sensitivity outcomes, while the total number of outcome measures and analyses recorded is greater. The record does not provide enough detail to determine how all outcome testing was planned or whether additional comparisons were prespecified. The secondary results are best read as supportive descriptive evidence about the measured outcomes, not as a complete assessment of visual performance or as proof of no difference.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Photopic Contrast Sensitivity With a Glare Source
• Mesopic Contrast Sensitivity With a Glare Source

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes are summarized as means and standard deviations. A mean describes the average value in the analyzed group; a standard deviation describes how spread out individual measurements are around that average. The standard deviation is not the same as the uncertainty in the mean. The standard error represents uncertainty in an estimated mean, and is generally smaller when more observations contribute, all else being equal. The posted summaries report both group sizes and standard deviations for the outcomes.

What does a mean difference express?

A mean difference subtracts one group mean from another. Its sign depends on the order of subtraction, so it is important to note which group is first. For the primary endpoint, the recalculation is expressed as without glare minus with glare, giving an estimate of 0.45. The registry's mixed-model result is expressed in the opposite direction, giving -0.45. Those values describe the same observed direction under different contrast ordering: the mean was lower in the with-glare condition.

For the Phase 2 outcomes, the recalculated contrast is test minus control. A negative estimate means the test group mean was lower than the control group mean in that summary. This direction is descriptive and does not, by itself, indicate whether the difference is statistically distinguishable from zero or important for visual performance.

How should the confidence interval be read?

A confidence interval gives a range of values compatible with the observed data and the statistical method used, at the stated confidence level. It communicates precision as well as direction. A narrow interval indicates less uncertainty about the estimated contrast than a wide interval, while an interval that includes zero is compatible with no mean difference under the calculation. The primary sponsor analysis reports a 95% confidence interval. The recalculated comparisons also have intervals, but they are unadjusted calculations from the posted summary statistics.

A p-value measures how unusual the data, or more extreme data, would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not quantify the size or practical importance of a difference. The primary recalculation has an unadjusted p-value <0.001. The Phase 2 recalculated p-values are 0.502 and 0.802. Because the latter are not small by common conventions, the summaries do not provide strong evidence against a zero difference under those unadjusted calculations. They are not proof of equivalence.

Why does the analysis model matter?

The registry reports a linear mixed model for the primary comparison and labels the reported estimate a least-square mean difference. A mixed model can represent outcome patterns that involve more than one source of variation or repeated measurements, depending on how it is specified. Least-square means are model-based estimates, rather than necessarily being the raw arithmetic group means. The registry record does not report the full model specification, its included terms, or the covariance structure, so those details cannot be evaluated from the posted analysis description.

The Phase 2 study is described as contralateral, meaning the study design assigns test and control lenses across the two eyes of a participant. Such data can be paired: measurements from the same person may be more alike than measurements from different people. A paired analysis can use that within-person relationship and may estimate a contrast differently from a calculation that treats group summaries as independent. The recalculated Phase 2 comparisons use posted summary statistics and are explicitly unadjusted. They do not reproduce a participant-level paired analysis. The registry record does not post sponsor analyses for these two outcomes.

What is over-dispersion, in general?

Over-dispersion is a concern when observed variability is greater than a statistical model assumes. If a method underestimates variability, its standard errors can be too small and its intervals too narrow. The posted outcomes are continuous means with standard deviations, and the record does not identify an over-dispersion analysis. No conclusion about over-dispersion can be drawn from the registry information alone. More generally, a sound analysis checks whether the model's assumptions reasonably describe the data, including the outcome distribution, dependence between observations, and variation across participants.

All recalculated p-values and intervals should be read as simple unadjusted comparisons based on posted summaries, not as a reconstruction of an unavailable full analysis plan. The registry record does not report the original sample-size justification, interim analysis procedures, or a multiplicity adjustment. Those omissions limit how completely the statistical methods can be assessed.

11. Confidence Intervals and Precision

The primary sponsor-reported 95% confidence interval for the least-square mean difference is -0.70 to -0.21. It lies on the negative side of zero for the reported contrast direction, indicating that the model-based estimate is more compatible with a lower mean in the with-glare group than the without-glare group. The interval gives a sense of uncertainty around that estimate; it does not mean that every value in the interval is equally likely, nor does it measure the range of individual participants' responses.

The unadjusted recalculation expresses the contrast in the reverse direction, without glare minus with glare. Its 95% confidence interval is 0.202 to 0.698. This interval also excludes zero, consistent with the reported primary result's direction after accounting for the reversed subtraction order. The two intervals arise from different reported approaches and should not be treated as identical estimates: one is the sponsor's mixed-model result, and the other is the simple recalculation from summary statistics.

The Phase 2 intervals are wider relative to their estimated differences and include zero: -0.118 to 0.058 for the photopic comparison and -0.088 to 0.068 for the mesopic comparison. They allow for differences on either side of zero in the unadjusted calculations. Their inclusion of zero means that these summaries do not rule out no difference, but it does not establish that the groups are equivalent or that any plausible difference is negligible.

Confidence intervals express statistical uncertainty conditional on the analysis and assumptions. In Phase 2, the posted recalculations do not account for the contralateral pairing. The registry record does not report enough model detail to assess the precision of a design-adjusted estimate for those outcomes. Thus, precision should be interpreted with that limitation in mind.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect sizes, not the trial's original design calculations. For these continuous outcomes, the figures are participants per arm, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; each planning scenario targets the stated fraction of the observed effect. The registry record does not report the trial's own original sample-size assumptions or justification.

The 80% power column gives the estimated participants per arm for a hypothetical study to have an 80% chance of detecting the specified effect if that effect were the true one, under the planning assumptions. The 90% power column describes the corresponding target for a 90% chance. These are design-planning quantities, not probabilities that the observed result is correct. This is not observed power.

Rows for 100%, 75%, and 50% of the observed effect illustrate how the planning estimate changes when the target difference is smaller than the effect observed in this study. Smaller effects require more participants per arm to detect at the same nominal power and significance level. This relationship is especially visible for the Phase 2 comparisons, whose observed differences are small relative to the variability in the outcomes. The sample-size illustrations do not establish that the trial was adequately or inadequately planned; that judgment would require its original design rationale and the relevant analysis plan.

The sample-size curves are another way to view the same planning relationship across effect assumptions. They should be interpreted as hypothetical design aids, not as additional observed trial results or as evidence that a particular number of participants would guarantee a finding.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.450; pooled standard deviation σ = 0.346.
2. n = 2 × (1.96 + 0.842)² × 0.346² / 0.450² = 9.3, rounded up to 10 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.45                      # observed difference in means
sigma <- 0.34613436697329                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5021081)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 10 (80% power), 13 (90% power)
 75% of observed effect: n per arm = 17 (80% power), 23 (90% power)
 50% of observed effect: n per arm = 38 (80% power), 50 (90% power)
power.t.test: 10.3 
Simulated power at n = 10 per arm: 0.786 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

For the primary endpoint, the registry reports the sponsor's own analysis as a linear mixed model estimating a least-square mean difference of -0.45, with a 95% confidence interval from -0.70 to -0.21. The reported estimate compares the groups in the direction that yields a negative value for the lower with-glare mean. The unadjusted recalculation gives 0.45 because it states the comparison in the reverse direction, without glare minus with glare. The reversed signs are not a disagreement about the direction of the observed result.

The sponsor's model-based analysis takes precedence over the simple recalculation when describing the primary analysis, because it is the registry's reported analysis. The recalculation is useful as a transparent check against the posted group summaries, but it does not reproduce the mixed model. The full model specification is not reported in the registry record, so its detailed assumptions cannot be independently assessed from the available description.

No sponsor-reported analyses are listed for the Phase 2 secondary outcomes. Their mean differences, intervals, and p-values are simple unadjusted recalculations from the posted summary statistics. In particular, they do not use participant-level information to account for the contralateral design. They should not be presented as sponsor estimates or as substitutes for a design-adjusted analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary outcome and two posted secondary outcomes, but it does not report a multiplicity adjustment or a hierarchy for interpreting multiple outcomes. Multiplicity refers to the increased opportunity for chance findings when several statistical tests are conducted. Adjustments or prespecified testing strategies can help control how the evidence is interpreted across a family of outcomes. Without a reported strategy, the Phase 2 recalculated p-values should be treated as unadjusted and exploratory rather than as a set of confirmatory tests.

Details of missing-data handling are not reported in the registry record. The outcome descriptions give analysis populations, including Phase 1 subjects who completed the phase without a major protocol deviation and exclusion of subjects with an increase in photopic contrast sensitivity under glare. The record does not explain how many participants were excluded for each reason, whether any measurements were missing, or how incomplete observations were handled. The Phase 2 summaries do not identify a missing-data method or a full participant flow.

The registry record also does not report a complete statistical analysis plan, the original sample-size justification, or whether any interim analyses were conducted. A detailed plan would help establish which outcomes and contrasts were prespecified, how the contralateral design was modeled, and how analysis populations and missing observations were defined. These details should not be inferred from the posted summaries.

The primary analysis is reported as a linear mixed model, but the model's specific terms and assumptions are not reported. For the Phase 2 secondary outcomes, no sponsor analysis is posted, and the available recalculations do not incorporate within-participant pairing. These gaps do not invalidate the posted numbers, but they constrain the strength and scope of conclusions that can be drawn from them. Interpretation should stay close to the reported endpoints, populations, and analysis methods.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry reports serious adverse events, other adverse events, and deaths for Phase 1 groups and for Phase 2 control and test groups. In every listed group, the reported counts for serious adverse events, other adverse events, and deaths are zero. The Phase 2 safety groups each list 62 at risk; the Phase 1 group sizes at risk vary across the listed lens categories. These are the registry's recorded figures for the safety populations described.

Zero reported events in these groups means that no events of those categories are recorded in the posted results for the listed at-risk participants. It does not show that an event is impossible, nor does it establish a precise absence of risk. The small Phase 1 group counts in particular limit what can be inferred from observing no events. The registry record does not provide additional detail about event collection, follow-up beyond the study phases, or adverse-event definitions in the information used for these results.

These counts should be read separately from the visual-performance outcomes. They describe reported safety events, not whether a lens changes contrast sensitivity. They also do not provide a basis for medical advice or conclusions about safety outside the study's recorded observation.

17. What the Result Does, and Does Not, Mean

The posted primary result describes photopic contrast sensitivity measured with and without glare in a selected Phase 1 population. The mean was lower in the with-glare condition, and the sponsor-reported confidence interval for its model-based contrast excludes zero. The outcome description presents this phase as an assessment of whether the glare source produced the intended contrast reduction before proceeding to Phase 2.

The primary result does not estimate the effect of the test lens versus the control lens. It is a glare-source comparison in Phase 1, not the randomized contralateral lens comparison. The Phase 2 secondary results address the latter comparison for photopic and mesopic contrast sensitivity with glare. Their unadjusted intervals include zero, but that does not demonstrate equivalence or rule out all potentially relevant differences.

The results also do not answer questions about visual outcomes that were not posted, performance in settings beyond the recorded assessments, or longer-term effects. The study was described as non-dispensing, with Phase 2 lens wear for approximately 3 hours. The registry record does not report broader follow-up or a full analysis plan. The specific measurements and short study context therefore set important boundaries on interpretation.

Statistical evidence is not the same as clinical importance. A confidence interval and p-value describe uncertainty under an analysis; they do not determine whether a difference matters to participants. The registry record does not give a clinical threshold for interpreting the Phase 2 test-control differences. The approximately 0.1 log-unit figure in the primary endpoint description is a stated glare-source progression criterion, not a general threshold for treatment benefit.

Overall, the record supports a focused description of the measured Phase 1 glare contrast and the posted Phase 2 summaries. It does not support a broad claim that one lens is superior, equivalent, or ineffective. Such conclusions would require an appropriate analysis of the randomized contralateral comparison, a clear prespecified interpretation framework, and evidence beyond the limited outcomes and timing recorded.

18. Why This Trial Matters Statistically

This study illustrates why endpoint labels, phase, and comparison direction matter. The registry's primary outcome is a Phase 1 glare-source assessment, while the title and Phase 2 design concern a test-versus-control lens comparison. Reading the primary contrast as a randomized lens effect would mix distinct questions and could lead to an incorrect interpretation.

It also illustrates the value of reporting uncertainty. Means alone show the observed averages, while confidence intervals describe uncertainty around contrasts. The primary sponsor interval and the unadjusted Phase 2 intervals tell different statistical stories, and neither should be reduced to a binary label. A non-significant secondary comparison does not establish equivalence, just as a statistically distinguishable primary contrast does not by itself establish clinical importance.

The contralateral design is a useful reminder that analysis should reflect how observations are collected. Measurements from two eyes of one participant may be related. Summary-statistic recalculations can be informative checks, but they cannot recover within-person relationships that are not included in the summaries. The absence of posted sponsor analyses for the Phase 2 outcomes therefore matters to how confidently those contrasts can be interpreted.

Finally, sample-size planning illustrations should not be mistaken for observed power or for the original trial justification. They show how a hypothetical design's participant requirements vary with the effect it seeks to detect. A careful reading distinguishes those planning scenarios from the trial's actual enrollment and outcome-specific analysis counts. Together, these principles support transparent, appropriately limited interpretation of clinical trial statistics.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry reports 82 participants enrolled overall, but the primary endpoint summaries include 15 subjects and the Phase 2 secondary summaries include 62 per lens group. A complete flow of participants through screening, phases, and analyses is not reported in the registry record. It is therefore not possible to fully account for the differences in analysis populations or to assess the effect of exclusions and missing outcomes.

The primary Phase 1 analysis population excludes subjects whose photopic contrast sensitivity increased with glare, as well as those with a major protocol deviation. This selection is part of the endpoint definition, but the record does not report the number excluded for each reason or the impact of those exclusions. The primary result should be understood as applying to the stated analyzed population, not automatically to everyone enrolled.

The Phase 2 study is described as contralateral, while the posted recalculations are based on group summary statistics and do not account for individual paired measurements. No sponsor analyses are posted for the secondary endpoints, and the statistical model details for the primary analysis are limited. These registry entries restrict direct comparison between the recalculated results and a fully design-aware analysis.

The registry record does not report a multiplicity strategy, detailed missing-data methods, the trial's original sample-size justification, or interim analysis procedures. It also provides only a limited description of follow-up and outcome assessment timing. These omissions limit assessment of prespecification, precision, and the scope of inference. The results concern measured contrast-sensitivity outcomes during the recorded study phases and should not be generalized to unreported outcomes or longer-term performance.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Visual Performance of Senofilcon A With and Without a New UV/HEV-filter — NCT05021081.
• Registry record last updated 2023-01-26; status last verified 2023-01.
• Results first posted 2023-01-26.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT05021081 is a completed randomized, double-masked study with an enrollment of 82. It included a non-randomized Phase 1 glare-source assessment and a randomized, double-masked, contralateral Phase 2 comparison of study lenses. The posted primary result is for Phase 1 photopic contrast sensitivity at 6 cpd; two Phase 2 contrast-sensitivity outcomes are posted as secondary results.

The sponsor reports a linear mixed model for the primary contrast. Phase 2 comparisons are unadjusted recalculations from posted summaries, with no sponsor-reported analyses listed. The record reports zero serious adverse events, other adverse events, and deaths in the listed groups. The original sample-size rationale, detailed analysis plan, multiplicity method, and missing-data handling are not reported in the registry record.