A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF) (NCT06698731), a randomized na study. The primary outcome is The Primary Effectiveness Endpoint for the Study is Monocular (Study [Right] Eye Only) Photopic Negative Lens-induced Distance-corrected Depth of Focus (DOF) at the 0.2 logMAR VA Threshold..

2. Clinical Question

3. Trial Design

This was a randomized, active-controlled, double-masked crossover study of the test lens and a distance-vision control lens. In a crossover design, participants receive each intervention in a planned sequence, so comparisons can draw on measurements made under both conditions in the same person. The registry describes two sequences: wearing the test lens before crossing over to the control lens, or wearing the control lens before crossing over to the test lens. It does not report the randomization method, period duration, washout arrangements, or how sequence and period effects were handled.

The record lists enrollment of 78 and status as completed. It gives a start date of 2024-10-28 and a primary completion date of 2025-01-13. The summary describes an office-based study using electronic vision-measuring equipment and says participants would make two visits. It also says study lenses would not be given to participants to take home. The planned study setting and procedure should be distinguished from outcome results: the primary endpoint is reported for Day 1, while the registry record does not explain the relationship between that endpoint timing and the crossover periods.

The endpoint population description states that all 77 eyes were analyzed for both the test and control lenses. That wording concerns eyes, not a reported count of distinct participants in the endpoint analysis. The adverse-event record gives 78 at risk for each lens. These different analysis descriptions should not be collapsed into one denominator: endpoint values and safety summaries may use different populations or reporting conventions, and the record does not explain the difference.

The phase is listed as NA. The sponsor is Bruno Vision Care. The record reports the primary outcome and two secondary visual-acuity outcomes, all with a Day 1 timeframe. It does not report a detailed statistical analysis plan, sample-size justification for the original study, or information about interim analyses.

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: The same 78 participants wore both test and control lenses in the same (study) eye. Randomization was done to determine sequence (test group is test lens first, and control group is control lens first).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All 77 eyes were analyzed for both Test and Control lenses

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.

6. Primary Endpoint

The registry lists the primary outcome as The Primary Effectiveness Endpoint for the Study is Monocular (Study [Right] Eye Only) Photopic Negative Lens-induced Distance-corrected Depth of Focus (DOF) at the 0.2 logMAR VA Threshold., measured over Day 1.

The primary endpoint is monocular photopic negative lens-induced distance-corrected depth of focus, measured in the study right eye at the 0.2 logMAR visual-acuity threshold. The procedure is described as adding small incremental negative lens power over distance-best-corrected vision until blurred vision is determined. The endpoint is expressed in diopters (D), and the registry reports a mean and standard deviation for each lens.

Conceptually, depth of focus describes the range over which vision remains at a specified acuity threshold as the optical demand changes. The chosen threshold makes the endpoint operational: it identifies a defined point in the testing procedure rather than relying only on a subjective impression of clear vision. The distance correction is relevant because the question concerns how vision behaves as additional lens power is introduced beyond distance-best-corrected vision. Photopic refers to testing under the stated light condition; the record also mentions interest in contrast under low illumination, but that is not the primary endpoint.

The primary endpoint is used to compare the test lens with a standardized distance-vision lens on this measured depth-of-focus outcome. It is a specific visual-performance measure, not a direct measure of every aspect of day-to-day vision, reading ability, visual comfort, or safety. The registry lists intermediate and near visual acuity as secondary outcomes, which address other viewing distances. Interpretation should therefore remain tied to the endpoint’s eye, lighting condition, acuity threshold, measurement procedure, and reported Day 1 timeframe.

7. Results Posted in the Registry

• Test: mean -2.22 versus -1.44 on control; difference -0.78 (95% CI -1.01 to -0.55), standardized effect d = -1.08; 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.

Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm

• 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: mean 0.01 versus 0.16 on control; difference -0.14 (95% CI -0.18 to -0.10), standardized effect d = -1.14; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Test than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm

• 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 errors.
• Result:
  • Test: mean 0.20 versus 0.35 on control; difference -0.16 (95% CI -0.56 to 0.25), standardized effect d = -0.12; z-test p = 0.445.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Test and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address visual acuity at intermediate and near viewing distances, complementing the primary depth-of-focus measure rather than duplicating it. At the level of the posted estimates, both comparisons favor a lower logMAR mean for the test lens, but the uncertainty differs between the outcomes: the intermediate comparison is more clearly separated, whereas the near comparison is much less precise and its interval includes zero. These are unadjusted summary comparisons, and no sponsor analysis is listed for either outcome.

The broad pattern is compatible with the study’s interest in vision at closer ranges, but it should not be treated as independent confirmation of the primary result. The primary outcome measures a different construct, at a specified visual-acuity threshold and under photopic conditions. Intermediate and near acuity are separate endpoints, with their own measurement distances and uncertainty. Results on one outcome do not automatically establish the result on another, and none of these measures alone captures all aspects of visual experience.

Secondary outcomes typically carry less evidential weight than a designated primary outcome because they may be exploratory and because examining several outcomes increases the chance of finding an apparently notable result by chance. Statistical adjustment for multiple comparisons can address some of that issue, but the registry does not report whether such adjustment was planned or performed. The secondary comparisons should therefore be read as supporting context, not as definitive tests. The record also does not report a detailed analysis plan establishing their prespecification or hierarchy.

Dispersion is reported differently for the two secondary measures: one is labeled with a standard deviation and the other with a standard error. Because these describe different features of the data, the values should not be compared directly as if they were a common measure of variability. The record does not provide further details about the calculation or analysis population for these secondary estimates.

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

• Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm
• Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes are measurements recorded on a numerical scale. For such an outcome, a mean gives the average value in a group, while a standard deviation describes how spread out individual measurements are around that average. These summaries make the groups and outcome scale easier to describe, but they do not show the full distribution of individual observations. They also do not, on their own, account for features of the trial design such as repeated measurements on the same participant.

What does the mean difference describe?

A mean difference expresses the contrast between two group means on the original measurement scale. In a comparison coded as test minus control, a negative value means the test mean is lower than the control mean. The endpoint’s direction must be understood from its measurement definition; a negative numerical difference is not automatically favorable or unfavorable. The reported unit for the primary outcome is D, so the contrast is expressed in that same unit.

The registry reports a crossover design. In general, crossover data include measurements from the same participant under more than one intervention. Statistical analysis can use that within-participant structure, and the relationship between a participant’s measurements can affect the estimated uncertainty. The unadjusted recalculations use posted arm-level summary statistics rather than participant-level paired observations. They therefore cannot incorporate the full within-participant relationship from the crossover unless the needed paired information is available. The record does not report that information.

What is ANCOVA?

ANCOVA is a regression-based approach that compares outcome means while accounting for specified covariates. The registry identifies the sponsor’s primary analysis as ANCOVA and labels its result a net mean difference. It does not identify the covariates, model specification, handling of sequence or period, or other details of that analysis. Consequently, the reported estimate can be described, but the model cannot be fully evaluated or recreated from the registry record alone.

The sponsor reports a 95% confidence interval and a p-value for the primary comparison. A confidence interval gives a range of values compatible with the data and the analysis under its assumptions; it conveys uncertainty about the estimated contrast. A p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the model assumptions held. It is not the probability that the null hypothesis is true, nor does it measure clinical importance.

Why distinguish the sponsor analysis from recalculation?

The posted recalculation is a simple, unadjusted calculation from summary statistics. It is useful as a check on the broad direction and scale of the comparison, but it is not equivalent to a design-aware model. Here, the recalculated central difference agrees with the sponsor’s reported central estimate, while the confidence intervals differ. This does not establish that the analyses used identical data or assumptions. The record marks no discrepancy, but the sponsor’s ANCOVA remains the reported primary analysis; the recalculated interval should be understood as a separate summary-based calculation.

Unadjusted p-values are reported for the primary and secondary summary comparisons. The primary sponsor analysis also has its own p-value. These values should not be treated as interchangeable because they arise from different analysis approaches. For the secondary outcomes, no sponsor analysis is listed. The registry does not report whether the sponsor adjusted for multiple comparisons, whether all outcomes were prespecified in a statistical plan, or how missing observations were handled.

What does a standard deviation or standard error mean?

A standard deviation describes variation among measurements. A standard error describes the estimated uncertainty of a mean, given the data and calculation used. The secondary outcome records do not use the same dispersion label: the intermediate acuity outcome is reported with a standard deviation, and the near acuity outcome is reported with a standard error. These quantities have different meanings and should not be compared as if they were the same measure of spread. The registry does not provide a further explanation of the near outcome’s dispersion entry.

In general, over-dispersion means the observed variation is greater than a model expects. If a method assumes less variation than the data contain, its uncertainty estimates may be too small and its tests too optimistic. No over-dispersion assessment is reported for these continuous outcomes, and the concept should not be read as a finding about this study. More generally, evaluating an analysis requires the model assumptions, outcome definitions, analysis population, and missing-data approach; several of these details are not reported in the registry record.

11. Confidence Intervals and Precision

Precision describes how narrowly an estimate is determined by the observed data and the assumptions of its analysis. The sponsor’s primary estimate is a net mean difference of -0.78 D, with a 95% confidence interval from -0.93 to -0.63. The interval does not include zero. Under the ANCOVA model and its assumptions, the interval represents values compatible with the observed data at the stated confidence level. It does not mean there is a 95% probability that the true difference lies within this particular interval.

The summary-based recalculation gives the same central estimate, -0.78 D, but its confidence interval extends from -1.009 to -0.551. This interval is wider than the sponsor’s reported interval and uses a different calculation. For a crossover study, a calculation based only on separate arm summaries cannot fully reflect the pairing of measurements within participants. The sponsor’s model details are not reported, so the reasons for the difference in interval width cannot be established from the registry record.

The interval is useful for judging statistical precision, but it does not establish whether the difference is large enough to matter in practice. The record does not report a clinically important threshold for this endpoint. Nor does a confidence interval account for every source of uncertainty: concerns about outcome measurement, analysis choices, missing data, or generalizability are not represented simply by its endpoints.

For the secondary outcomes, uncertainty differs between the intermediate and near comparisons. Their posted intervals and p-values are unadjusted calculations, and the registry does not list sponsor analyses for those outcomes. They should be interpreted as exploratory evidence rather than as an extension of the primary ANCOVA result. No conclusion about the precision of participant-level paired effects can be drawn from summary statistics alone.

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 planning figures are participants per arm, not total events. They are illustrations based on the observed effect, not the original study’s design calculation. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the planned number of participants per arm that would give an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions were correct. The 90% power column expresses the corresponding planning target for a 90% chance. These are prospective design illustrations, not guarantees about the outcome of a future study. The displayed rows consider planning for 100%, 75%, and 50% of the observed effect. Smaller effects require more participants to detect under the same assumptions, which is why the planning counts rise as the effect being targeted becomes smaller.

These values are not observed power. Observed power is not a useful substitute for interpreting the estimate and its confidence interval after a study has been completed. The figures also should not be treated as a design recommendation: the original study is a crossover trial, while the planning assumptions describe equal allocation between two arms and a normal approximation. The record does not establish that this illustration reproduces the design or analysis structure used in the trial.

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 = -0.780; pooled standard deviation σ = 0.725.
2. n = 2 × (1.96 + 0.842)² × 0.725² / -0.780² = 13.6, rounded up to 14 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 <- -0.78                      # observed difference in means
sigma <- 0.724796523170469                     # 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(6698731)
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 = 14 (80% power), 19 (90% power)
 75% of observed effect: n per arm = 25 (80% power), 33 (90% power)
 50% of observed effect: n per arm = 55 (80% power), 73 (90% power)
power.t.test: 14.6 
Simulated power at n = 14 per arm: 0.782 (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

The sponsor’s reported primary result comes from ANCOVA and is a net mean difference of -0.78, with a 95% confidence interval from -0.93 to -0.63 and p < 0.001. The separate recalculation uses the posted arm-level means and dispersion summaries. It gives a mean difference of -0.78, a confidence interval from -1.009 to -0.551, and p < 0.001. The matching central estimate indicates agreement in the reported direction and magnitude, while the different intervals reflect different calculations.

The recalculation is unadjusted and summary-based. It does not reproduce the sponsor’s ANCOVA, whose covariates and model details are not reported. It also cannot make full use of within-participant pairing in a crossover design without the paired observations. The sponsor’s analysis is the registry’s reported analysis for the primary outcome, while the recalculation offers a distinct, limited check on the posted summaries. The record marks no discrepancy between the analyses, but that does not make their methods interchangeable.

No sponsor analyses are listed for the secondary outcomes. Their posted comparisons should therefore be kept separate from the sponsor’s primary result and interpreted with the limitations of unadjusted summary calculations.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes or comparisons are examined. Even when each individual test uses a conventional threshold, looking across multiple tests increases the possibility that at least one result will appear statistically notable by chance. The registry lists a primary endpoint and two secondary endpoints, and the posted results include comparisons for each. It does not report whether the statistical plan adjusted for multiple testing, whether the secondary outcomes were confirmatory or exploratory, or what hierarchy was intended among them.

The primary outcome has a sponsor-reported ANCOVA. The two secondary outcomes have posted unadjusted recalculations but no sponsor analyses listed. This difference in reporting matters: the secondary results should not be treated as if they shared the same model or inferential status as the primary result. The record does not give enough information to determine whether the outcome definitions, analysis methods, or multiplicity approach were finalized before data were examined.

Missing-data handling is also not reported in the registry record. The primary endpoint description says all 77 eyes were analyzed for both lenses, while the safety summaries list 78 at risk for each lens. The record does not explain why these reporting counts differ, whether any outcome data were missing, how missing measurements were treated, or whether participants were excluded from particular analyses. The values should therefore be cited according to their stated outcome and population description rather than interpreted as a single common denominator.

The crossover design raises additional analysis questions. The record does not describe whether the model accounted for period, sequence, or within-participant correlation, nor does it report procedures for assessing carryover. This absence does not establish that those considerations were ignored; it means the registry entry does not document how they were addressed. Without the full analysis plan and participant-level data, the handling of missingness, multiplicity, and crossover structure cannot be independently assessed.

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 0% reporting threshold.

For the test lens, the registry lists 78 at risk, zero serious adverse events, zero other adverse events, and zero deaths. For the control lens, it likewise lists 78 at risk, zero serious adverse events, zero other adverse events, and zero deaths. No serious adverse-event terms are listed. These entries describe what was reported in the registry safety summary for each lens.

Zero recorded events does not establish that no possible adverse effects exist, and it does not show that the lenses have identical safety profiles. Interpretation depends on how events were defined, collected, attributed, and followed over time. Those details, including event-specific observation periods and severity criteria, are not reported in the registry record. The record also does not explain how the safety population relates to the eyes analyzed for the visual endpoints.

The safety figures should therefore be read as a report of no events in the listed categories among those recorded as at risk, rather than as proof of absence of risk. They also do not resolve the separate study question about visual disturbance or safety concerns beyond the adverse-event categories summarized.

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

The primary result describes a difference between the test and control lens means on a specific measure: monocular photopic distance-corrected depth of focus in the study right eye at the 0.2 logMAR threshold. The sponsor’s ANCOVA estimate is -0.78 D, with a 95% confidence interval from -0.93 to -0.63. This is evidence of a difference on the measured endpoint under the sponsor’s analysis and assumptions. The direction is determined by the comparison coding and should not be translated into a broad claim about clinical benefit without reference to the endpoint definition.

The result does not by itself establish how participants functioned in everyday settings, whether they preferred one lens, or whether the measured difference was clinically important. The registry does not report a clinically meaningful threshold for this endpoint. Nor does the primary measure establish performance under low illumination: the summary mentions low-light contrast as an interest, but the listed primary endpoint is photopic. Intermediate and near acuity are reported separately and should not be collapsed into the primary outcome.

The crossover design means that each participant was intended to experience both lenses, with sequence variation. This can support within-person comparison, but proper interpretation depends on how repeated measurements, period, sequence, and possible carryover are handled. The statistical details are not reported in enough depth to assess those features. The arm-summary recalculation does not replace a model that uses the crossover structure.

The record reports no adverse events in the listed categories, but that is not evidence that every potential visual disturbance or safety concern was excluded. It also does not establish results for populations or settings beyond those represented in the study. The record gives limited detail about participant characteristics, missing observations, outcome collection, and generalizability. The result is therefore best understood as a statistical comparison on the specified endpoint in the reported study, rather than as a complete account of clinical performance or safety.

18. Why This Trial Matters Statistically

This trial illustrates why a clinical result needs to be read at the level of its endpoint and design. The primary question is not simply whether one lens has a different mean: it concerns a defined optical measurement, taken in one study eye under photopic conditions and evaluated at a specified acuity threshold. Keeping that measurement definition in view prevents a numerical comparison from being overstated as a conclusion about every distance, lighting condition, or aspect of vision.

The crossover structure is also statistically important. Measurements from the same participant under both lenses can be related, and that relationship can influence uncertainty. The sponsor reports an ANCOVA, while the posted recalculation is based on group-level summaries. Their central estimates agree, but the different intervals demonstrate why an unadjusted summary calculation should not be mistaken for a reproduction of a design-aware analysis.

The secondary outcomes add context but also raise questions about multiplicity and interpretation. Multiple visual outcomes can describe different parts of performance, yet they do not automatically provide independent confirmation. The registry does not report the multiplicity strategy or detailed analysis hierarchy, so secondary evidence deserves caution.

Finally, the record distinguishes statistical evidence from practical importance. A confidence interval and p-value help describe uncertainty under an analysis, but they cannot supply a clinical threshold that the registry does not report. Likewise, an absence of recorded adverse events is not a universal safety conclusion. Clear communication depends on preserving these boundaries between measurement, statistical inference, and broader interpretation.

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.

Several trial-specific details needed for a fuller assessment are not reported in the registry record. These include the ANCOVA covariates and model specification, how the crossover periods and sequences were handled, whether within-participant correlation was incorporated, and whether carryover was assessed. Period duration and washout arrangements are also not described. These omissions limit independent evaluation of the primary analysis, even though the sponsor’s result is reported.

The endpoint analysis description refers to 77 eyes for each lens, while safety summaries list 78 at risk for each lens. The record does not explain this difference or describe exclusions, missing endpoint data, or the analysis population for the secondary outcomes. The near visual-acuity dispersion is labeled as a standard error, unlike the standard deviation reported for the intermediate outcome; further calculation details are not provided.

The record does not report a clinically important threshold for the primary endpoint, a detailed sample-size justification for the original trial, or a multiplicity plan. The planning illustrations are not the trial’s original design calculation. Participant characteristics beyond the summary description, and the representativeness of the study population, are not reported in sufficient detail to assess generalizability.

The study summary describes visual assessment in an office setting and says lenses would not be taken home. This context may differ from everyday use, but the registry does not provide additional information to evaluate that difference. Low-light contrast and visual disturbance are mentioned as study interests, while the posted outcomes do not include a corresponding reported result. These limitations call for a narrow reading of the recorded primary endpoint and caution in extending it to other conditions or outcomes.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF) — NCT06698731.
• Registry record last updated 2026-03-17; status last verified 2026-02.
• Results first posted 2026-03-17.
• 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

The registry record describes NCT06698731, a completed randomized, active-controlled, double-masked crossover study sponsored by Bruno Vision Care. It lists enrollment of 78 and compares the Deseyne (Vifilcon C) test lens with a standardized distance-vision control lens. The primary outcome is monocular photopic distance-corrected depth of focus at the 0.2 logMAR threshold on Day 1.

The sponsor’s primary ANCOVA reports a net mean difference of -0.78 D, with a 95% confidence interval from -0.93 to -0.63 and p < 0.001. The registry also lists secondary intermediate and near visual-acuity outcomes, summary-based comparisons, and zero reported serious or other adverse events and deaths for each lens. Analysis details concerning the crossover structure, missing data, and multiplicity are not reported in the registry record.