The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses (NCT05766787), a randomized na study. The primary outcome is Least Squares Mean Distance VA With Study Lenses at Week 1.

2. Clinical Question

In statistical terms, the comparison concerns a continuous visual-acuity measure observed during two lens periods in a randomized crossover design. Each participant could contribute experience with both lens types, but the posted arm counts and summary statistics do not describe the pairing of individual measurements. The reported outcome is specifically at Week 1 of each lens period, not a summary of all wearing days. The study purpose was to assess clinical performance during daily wear; the primary posted measure addresses distance visual acuity, not every aspect of lens performance.

3. Trial Design

The registry describes a randomized, double-masked, crossover study of two reusable silicone hydrogel contact lenses. The trial is listed as completed, with enrollment of 190. It started on 2023-03-29, and primary completion was 2023-06-02. Its phase is listed as NA. Alcon Research is the sponsor.

The randomized crossover structure assigned participants to one of two orders. In one sequence, serafilcon A contact lenses (LID022821) were worn first and senofilcon A contact lenses (AOHP) second. In the other, the order was reversed. Each lens type was worn bilaterally for approximately 14 days, and CLEAR CARE was used for daily cleaning and disinfection. The record does not report additional detail about how the crossover periods were separated or whether any transition procedures were used.

Because each participant was assigned a sequence involving both lens types, this is not simply a parallel-group comparison in which each participant wears only one study lens. In general, crossover designs can compare treatments within participants, which can account for stable differences between people. They also require attention to period, sequence, and possible carryover effects. The registry record does not report the statistical model or how those design features were addressed in the analysis, so no particular adjustment should be assumed.

The primary outcome population was the Full Analysis Set, defined as all randomized subjects exposed to any study lenses and evaluated in the study with data at the Week 1 visit. The displayed outcome counts are 181 for LID022821 and 185 for AOHP. The registry does not explain why these counts differ from the total enrollment or from one another, nor does it describe the handling of incomplete or unavailable measurements. The posted results include one outcome measure and one analysis. Details of the original sample-size justification and other design assumptions are not reported in the registry record.

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.

Before assignment: Of the 190 enrolled, 3 participants were exited prior to randomization as screen failures. Of the 187 randomized, 1 participant was discontinued prior to exposure to the study lenses due to ocular pre-treatment adverse events. This reporting group includes all participants exposed to any study lenses (186).

First Wear Period, Approximately 7 Days

Reasons for not completing this period:

Second Wear Period, Approximately 7 Days

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this study with data at Week 1 visit.

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: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.

6. Primary Endpoint

The registry lists the primary outcome as Least Squares Mean Distance VA With Study Lenses at Week 1, measured over Week 1 of each lens product worn during the corresponding crossover period.

The primary endpoint is least squares mean distance visual acuity with study lenses at Week 1 of each lens product worn during its corresponding crossover period. Visual acuity was assessed separately for each eye while the study lens was in place, using logarithmic Minimum Angle of Resolution (logMAR) reading charts. The measure is continuous and is reported in logMAR units.

The registry explains the scale: logMAR values typically range from -0.3, corresponding to 20/10 vision on the Snellen chart, to 1, corresponding to 20/200 vision. A value of 0.0 corresponds to 20/20 Snellen acuity, and negative values denote better than 20/20 visual acuity. Thus, the posted negative group means represent acuity on the better-than-20/20 side of that reference point, as described by the record. The group means are -0.11 for LID022821 and -0.1 for AOHP.

General: a continuous endpoint retains information about the measured scale rather than reducing outcomes to categories. Distance visual acuity is relevant to the trial's stated objective of assessing lens performance, because it records how clearly participants read the distance chart with each lens in place. It is not, by itself, a complete measure of all clinical performance, comfort, safety, or other outcomes. The registry lists no secondary posted outcomes, so the endpoint does not establish findings on measures that are not reported.

The registry reports the outcome as a least squares mean, a model-based mean in general statistical usage. However, the analysis method used to obtain that estimate is not reported in the registry record. The posted arm summaries include a standard error of 0.005 for each lens group.

7. Results Posted in the Registry

• AOHP: mean -0.10 versus -0.11 on control; difference 0.01 (95% CI -0.00 to 0.02), standardized effect d = 0.15; z-test p = 0.157.

8. Statistical Interpretation

9. Statistical Methods Explained

General: continuous outcomes are measurements on a numeric scale where differences can be described in the scale's units. Here, the endpoint is distance visual acuity in logMAR. The posted arm values are least squares means, while the arm-level dispersion is reported as a standard error of 0.005 for each group. A standard error describes the uncertainty of an estimated mean, not the spread of individual participants' measurements. The record does not report a standard deviation for each arm or the model used to calculate the least squares means.

The simple recalculation uses the posted group summaries to estimate an unadjusted mean difference of 0.01. Its 95% confidence interval extends from -0.004 to 0.024, and the unadjusted p-value is 0.157. These recalculated values are not the sponsor's analysis. They are summaries based on posted means, standard errors, and group counts, and do not include a crossover-specific model. The pooled standard deviation is approximate, as indicated in the statistical record, and the standardized effect estimate is 0.148. Because that standard deviation is approximate, the standardized result should be read as an approximation rather than a precise reconstruction of participant-level variation.

General: a confidence interval is a range produced by a statistical procedure that reflects uncertainty in an estimate. It communicates more about precision than a point estimate alone. A confidence interval that includes zero does not show a clear direction of difference under the corresponding unadjusted comparison, but it does not prove the groups are exactly equal. The interval's bounds also do not define whether a difference is clinically important; that requires a relevant threshold, which is not reported in the registry record.

General: a p-value is calculated relative to a null hypothesis and a statistical model. The unadjusted p-value of 0.157 is not a probability that the observed result occurred by chance, nor is it the probability that the two lenses are equivalent. Its interpretation depends on the assumptions and structure of the analysis. No multiplicity adjustment or testing hierarchy is reported. The registry's own analysis is identified as non-inferiority, but it does not include the method, a p-value, or a usable interval range in the posted fields.

The design is crossover, meaning participants were assigned sequences in which both study lens types were worn. General: crossover analyses often need to account for correlation between measurements from the same participant, along with period and sequence effects. Carryover can also matter if an effect from one period persists into the next. These considerations are not reasons to assume that an analysis is invalid; they identify aspects that would ordinarily be assessed when interpreting crossover results. The registry record does not report the sponsor's model or how it handled these features.

Least squares means are generally model-based estimates adjusted for terms in a specified model. The label alone does not reveal which terms were included, whether the estimates account for the crossover structure, or how missing data were handled. Those details are not reported in the registry record. The Full Analysis Set definition does identify who was included: randomized subjects exposed to any study lenses and evaluated at Week 1 with data. It does not describe the number excluded from the primary analysis or the reason for any missing observations.

General: over-dispersion means that outcome variability is greater than assumed by a statistical model. If present and not accommodated, uncertainty estimates can be too small, making results appear more precise than warranted. This is a general consideration rather than a reported feature of this trial. The outcome is continuous, and no evidence about over-dispersion or a model diagnostic is reported in the registry record.

For the planning illustrations, the stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set as a stated fraction of the observed effect. These are assumptions for the posted planning calculations, not documented assumptions for the original trial design. The registry's original sample-size justification, planned effect, and analysis specifications are not reported. The planning estimates therefore should not be used to infer what the trial was designed to detect or what statistical approach its sponsor used.

The sponsor-reported result and the recalculation answer related but not identical questions. The sponsor result is labelled least squares mean difference and non-inferiority. The recalculated estimate is an unadjusted mean difference based on the posted summaries. Because the registry does not state the sponsor model, non-inferiority margin, or sign convention, the numerical outputs cannot be reconciled fully from the record alone. The sponsor's reported analysis is the trial's own analysis; the unadjusted recalculation is a separate descriptive check.

10. Confidence Intervals and Precision

The unadjusted recalculation estimates a mean difference of 0.01 logMAR, with a 95% confidence interval from -0.004 to 0.024. The interval spans zero, so the recalculated data do not isolate a difference in one direction. Its range also indicates that the point estimate should not be treated as exact. The interval is tied to the unadjusted calculation and should not be confused with an interval from the sponsor's crossover analysis.

General: a confidence interval describes the uncertainty associated with an estimate under the procedure and assumptions used to construct it. A narrower interval indicates greater precision under those assumptions; a wider interval indicates greater uncertainty. Precision is distinct from clinical importance. To decide whether the range represents a meaningful difference would require a clinically relevant threshold, which is not reported in the registry record.

The group standard errors are 0.005 for LID022821 and 0.005 for AOHP. Standard errors describe the estimated means' uncertainty, not the range of individual visual-acuity observations. The pooled standard deviation used for the recalculation is approximate, and its value is 0.068. The resulting standardized effect estimate is 0.148. Since the posted recalculation uses arm summaries rather than participant-level paired data, it does not directly reflect the within-participant correlation expected in a crossover comparison.

The registry's own result is labelled non-inferiority and reports a least squares mean difference of -0.01. The lower and upper confidence-limit fields are each reported as -0.01, rather than a distinct interval range, and no p-value is posted for that analysis. The non-inferiority margin is not reported in the registry record. Those omissions limit assessment of the precision and interpretation of the sponsor's result. The recalculated interval supplies a separate unadjusted description of uncertainty, not a replacement for the trial's own analysis.

11. 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 planning estimates are participants per arm, not total events. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. The trial's own original design assumptions and sample-size justification are not reported in the registry record, so these calculations should be read only as planning illustrations.

The 80% power column gives the estimated number of participants per arm for a planning scenario designed to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and those assumptions were the true planning basis. The 90% power column gives the corresponding number of participants per arm for a scenario with a 90% chance under those assumptions. These are prospective planning concepts, not descriptions of the probability that the completed trial detected an effect.

The calculations consider planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. For 100% of the observed effect, the estimates are 719 participants per arm for 80% power and 962 for 90% power. For 75% of the observed effect, they are 1,277 per arm for 80% power and 1,710 for 90% power. For 50% of the observed effect, they are 2,874 per arm for 80% power and 3,847 for 90% power. The 50% scenario requires more participants than the scenarios based on larger effects: smaller effects are harder to distinguish from random variation and therefore require more information.

These figures are not observed power. They do not describe what the completed trial achieved, and they do not establish that the trial was adequately or inadequately sized for its original purpose. The registry does not report the original target effect, design calculation, or justification. The calculations also use equal allocation between two arms, whereas the posted outcome counts are 181 and 185 and the trial itself used a crossover design. The planning illustration is therefore best used to understand how required sample size changes under its stated assumptions, not as a reconstruction of the trial's design.

12. 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 = 0.010; pooled standard deviation σ = 0.068.
2. n = 2 × (1.96 + 0.842)² × 0.068² / 0.010² = 718.3, rounded up to 719 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 <- 0.01                      # observed difference in means
sigma <- 0.067642807825736                     # 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(5766787)
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 = 719 (80% power), 962 (90% power)
 75% of observed effect: n per arm = 1,277 (80% power), 1,710 (90% power)
 50% of observed effect: n per arm = 2,874 (80% power), 3,847 (90% power)
power.t.test: 719.2 
Simulated power at n = 719 per arm: 0.803 (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.

13. Analyses Reported by the Sponsor

The registry's own analysis is labelled non-inferiority and reports a least squares mean difference of -0.01. The lower and upper confidence-limit entries are both -0.01, and no p-value is reported for that analysis. The registry does not report the non-inferiority margin, the analysis method, or the convention used to define the direction of the difference. The posted result therefore cannot be assessed against a stated non-inferiority criterion from the registry record alone.

The unadjusted recalculation uses the posted arm summaries and estimates a mean difference of 0.01, with a 95% confidence interval from -0.004 to 0.024 and an unadjusted p-value of 0.157. The numerical sign differs from the sponsor-reported value. A reversal in subtraction order could reverse a sign, but the registry does not state the sponsor's convention, so that explanation cannot be confirmed. The recalculation is also not a reproduction of the sponsor's least squares analysis; it is a simple summary-based comparison and does not account for the crossover structure.

Both results should be read according to what they report: the sponsor's non-inferiority-labelled least squares mean difference, and a separate unadjusted recalculation. The recalculated confidence interval is not the sponsor's confidence interval. The sponsor's own interval fields and missing margin prevent a full comparison of inferential conclusions. The registry does not identify the detailed statistical model, so the reason for any difference between the two analyses cannot be established from the posted information.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and one analysis, and it reports no secondary posted outcomes. It does not state whether the primary comparison was part of a broader set of planned tests, whether an adjustment for multiple comparisons was considered, or whether any testing hierarchy was specified. With only one posted outcome measure, the record does not establish that no other analyses were conducted; it establishes only what is included in the registry results.

General: multiplicity arises when multiple hypotheses or outcomes are assessed. If many tests are considered, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for that multiplicity. No such plan or adjustment is reported in the registry record. The recalculated p-value of 0.157 is explicitly unadjusted and should not be treated as a multiplicity-adjusted result.

The primary population is defined as the Full Analysis Set: all randomized subjects exposed to any study lenses evaluated in the study with data at Week 1. The registry does not report the number of randomized participants who lacked Week 1 data, the reasons for missing measurements, or the method used to handle missing data. The outcome counts of 181 for LID022821 and 185 for AOHP do not by themselves explain how records were included or excluded, particularly in a crossover design where participants may contribute observations in both periods.

The registry also does not report whether analyses were conducted in additional populations, such as all randomized participants or participants who completed both periods. The missing-data assumptions and any sensitivity analyses are not reported in the registry record. General: missing observations can affect estimates if their absence is related to participant characteristics or outcomes; the direction and size of any effect depend on the pattern and assumptions. Without the missingness details, no claim about the impact of missing data can be made.

The sponsor result is labelled non-inferiority, but the margin, analysis method, and decision procedure are not reported. For a non-inferiority question, the margin is essential to define what difference is considered acceptable for that analysis. The registry record does not establish the intended margin or provide enough detail to assess how missing data, crossover periods, or multiple testing were handled.

15. 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 serious adverse event figures show zero serious events among those at risk in each listed group. The registry reports 0 serious events among 186 at risk in Pretreatment; 0 among 364 at risk in LID022821 - Ocular; 0 among 182 at risk in LID022821 - Non-Ocular; 0 among 370 at risk in AOHP - Ocular; and 0 among 185 at risk in AOHP - Non-Ocular. The record also reports zero deaths.

These are the serious adverse event counts and denominators recorded for the named groups. The denominators differ across groups, and the registry does not explain their construction in the posted information. In a bilateral lens study, the ocular group counts should not automatically be interpreted as counts of unique participants; the registry provides group-level at-risk figures but does not describe their unit in further detail.

General: observing no reported serious events in a group does not demonstrate that the true risk is zero. Event counts are descriptive and their interpretation depends on the number followed, length of observation, event definitions, and completeness of reporting. The registry's serious-event figures should not be extended to non-serious events or to safety outcomes not represented in these fields. The listed figures also do not provide a comparative statistical analysis of safety between lenses.

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

The primary results describe distance visual acuity at Week 1 of each lens period. The posted least squares means are -0.11 logMAR for LID022821 and -0.1 logMAR for AOHP. The simple unadjusted recalculation estimates a mean difference of 0.01, with a 95% confidence interval from -0.004 to 0.024 and an unadjusted p-value of 0.157. Those quantities describe the observed summaries and the uncertainty of that particular recalculation; they do not by themselves establish a clinically important distinction or equivalence.

The sponsor's analysis is labelled non-inferiority and reports a least squares mean difference of -0.01. The registry does not provide the non-inferiority margin, a usable confidence interval range, or a p-value for that analysis. Without the margin and analytical details, the non-inferiority label cannot be converted into a complete conclusion about whether a prespecified criterion was met. The sponsor's result and the simple recalculation also have different numerical signs, and the record does not explain the sign convention.

General: absence of a clear difference in an unadjusted comparison is not proof that two treatments are identical. Likewise, a point estimate alone does not establish that any difference matters to patients or clinicians. Clinical interpretation would require a relevant threshold and a design-specific analysis, neither of which is available in the registry record. The recalculation is not a substitute for a model that may account for the within-participant structure of the crossover trial.

The primary endpoint addresses distance acuity with study lenses at the specified Week 1 visits. It does not establish performance for other wearing periods, outcomes, or conditions. The registry's study purpose is broader than visual acuity alone, but no secondary outcomes are posted. The record also does not provide a detailed analysis model, missing-data approach, or information about period and sequence effects. These gaps limit how far the result can be generalized beyond the posted endpoint and its observed population.

Safety information is similarly specific to the posted serious adverse event counts: none are reported in the listed groups, and no deaths are reported. Those figures do not establish an absence of all harms or permit a full comparison of safety across lenses. The defensible reading is therefore narrow: the record provides Week 1 distance visual-acuity summaries, a sponsor-reported non-inferiority-labelled result with limited inferential detail, and serious adverse event counts for the named groups.

17. Why This Trial Matters Statistically

Statistically, this trial is notable because its randomized crossover structure affects how a lens comparison should be analyzed. Participants were assigned to one of two sequences and wore both lens types. General: a crossover design can make within-participant comparisons informative because each person can serve as their own reference. That benefit depends on appropriate treatment of correlation between periods and consideration of period, sequence, and possible carryover effects. The registry describes the design but does not report how the sponsor's analysis addressed these features.

The posted outcome is a continuous visual-acuity measure with a defined logMAR scale. Its two arm summaries are close in numerical value, and the unadjusted recalculation reports a mean difference of 0.01 with a 95% confidence interval from -0.004 to 0.024. That interval makes uncertainty visible rather than reducing the result to a binary label. The trial's own analysis, however, is labelled non-inferiority, which requires an interpretation grounded in a prespecified margin. The margin is not reported, leaving an important part of the statistical question unresolved.

The distinction between a sponsor's model-based result and a simple recalculation is also instructive. A least squares mean may reflect a specified model, while a summary-based unadjusted calculation does not reproduce that model. Here, the sponsor method and sign convention are not given, so the analyses cannot be reconciled completely. Showing both perspectives helps distinguish what can be checked from posted summaries from what depends on unreported analytical details.

Finally, the planning illustrations make clear that sample-size requirements depend on the effect chosen for planning and on assumptions about allocation and statistical method. They are not evidence about the trial's original design or its achieved power. Taken together, the record illustrates why endpoint definition, design-aware analysis, uncertainty, and transparent reporting of margins and methods all matter when interpreting a clinical trial result.

18. 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 does not report the statistical model used for the least squares means or the sponsor's non-inferiority analysis. It also does not report the non-inferiority margin, a p-value for the sponsor analysis, or a distinct lower and upper confidence-limit range; both confidence-limit entries are -0.01. These omissions prevent full appraisal of the sponsor's inferential result.

The simple recalculation is unadjusted and based on posted summary statistics. The study is a crossover trial, but the recalculation does not use participant-level paired observations and does not account for within-participant correlation, period, sequence, or possible carryover. The pooled standard deviation is approximate. The registry does not provide sufficient detail to determine how the sponsor's analysis addressed those design features.

The primary analysis population requires Week 1 data after exposure to study lenses, but the record does not describe missing observations, exclusion reasons, or missing-data methods. It also does not report whether other analysis populations or sensitivity analyses were used. Although one outcome measure and one analysis are posted, the registry does not state whether other planned outcomes or tests were considered or whether multiplicity was addressed.

The posted endpoint is limited to distance visual acuity at Week 1 of each lens period. No secondary outcomes are posted, so conclusions about other aspects of lens performance cannot be drawn from the reported outcome. The safety figures list serious adverse events by named groups, but the record does not further explain the denominators or provide a comparative safety analysis. The original sample-size justification and design assumptions are not reported; planning illustrations based on the observed effect do not fill that gap.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses — NCT05766787.
• Registry record last updated 2024-06-13; status last verified 2024-05.
• Results first posted 2024-06-13.
• 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.

22. Record Summary

NCT05766787 is a completed, randomized, double-masked crossover study sponsored by Alcon Research. It enrolled 190 participants and compared serafilcon A contact lenses (LID022821) with senofilcon A contact lenses (AOHP). The two lenses were worn in randomized order, bilaterally, for approximately 14 days per lens type, with CLEAR CARE used for daily cleaning and disinfection.

The primary outcome was least squares mean distance visual acuity at Week 1 of each lens period, measured in logMAR. The posted means are -0.11 for LID022821 and -0.1 for AOHP. An unadjusted recalculation gives a mean difference of 0.01, a 95% confidence interval from -0.004 to 0.024, and an unadjusted p-value of 0.157. The registry's own analysis is labelled non-inferiority and reports -0.01, but its margin and analysis details are not reported.

The serious adverse event figures report zero events in each listed group and zero deaths. The registry does not report secondary outcomes, the original sample-size justification, or detailed methods for the sponsor analysis, missing data, or crossover effects.