Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers (NCT06053463), a na na study. The primary outcome is Visual Analog Scale.

2. Clinical Question

The clinical question is about reported wear experience rather than a comparison of treatments. A visual analog scale can capture a participant’s own assessment of symptoms, which may be relevant when the aim is to describe how lens wear feels. In this record, the outcome is reduced to a positive-versus-not-positive classification using the stated threshold. That classification addresses whether scores crossed the threshold, not the full range or pattern of participants’ scores.

Because there is no comparator group, the study cannot establish how these reports differ from reports under another lens or under a different condition. Its design instead describes the experience among participants who wore the study lenses. The registry record does not report a more detailed primary hypothesis, a comparison target, or the number of participants who met the positive-score definition.

3. Trial Design

This is a completed, single-group study with enrollment of 35. The registry record lists the study as having no masking, and allocation is listed as NA. The intervention is a daily disposable multifocal soft contact lens; the study summary names Dailies TOTAL1 Multifocal. The group description says participants would wear contact lenses during the day for about a month.

The listed condition is presbyopia. The intended population is more specifically described in the summary as presbyopic adults who had previously dropped out of contact lens wear. The registry record does not report further eligibility details, such as the criteria used to define prior dropout or the range of presbyopia represented in the study population.

The primary outcome is a visual analog scale survey of lens wear symptoms related to vision. Its timeframe is 1 month, and the outcome description defines a positive score as > 50. The outcome is recorded as a count of participants, although the registry record does not report that count or the corresponding percentage. Two outcome measures are listed in total; details of the other measure are not reported in the registry record.

The study is marked completed. Its listed start date is 2023-10-06 and its listed primary completion date is 2024-05-23. These dates describe the registry record’s timeline; they do not supply participant-level follow-up information. The record does not report how many participants completed the intended lens-wear period or how many contributed data to each outcome.

With no separate control group and no masking, the design is descriptive rather than a randomized comparative trial. It can characterize reported outcomes among participants in the lens-wear group if those outcomes are reported, but it cannot isolate a lens effect from other explanations through a concurrent group comparison. The registry record does not report a detailed statistical analysis plan or a sample-size justification for the study itself.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants

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 Visual Analog Scale, measured over 1 month.

The primary endpoint is a participant count based on a visual analog scale survey about vision symptoms while wearing contact lenses. The registry description defines a positive score as > 50, and gives the timeframe as 1 month. The measure is therefore a thresholded summary: each participant’s score is classified according to whether it passes the stated cutoff.

In general, participant-reported scales are used to describe experiences that are difficult to assess solely through an external measurement, such as perceived vision symptoms during wear. A threshold can make the outcome easier to summarize as the number of participants meeting a stated criterion. That can be useful for describing how many participants reported scores on one side of a cutoff, but it does not convey the full distribution of scale values. Scores just on opposite sides of the cutoff are placed in different categories, while scores farther apart on the same side remain in one category.

The registry record does not report the observed participant count, the percentage with positive scores, the distribution of scale scores, or a confidence interval. It also does not report details such as the precise survey administration procedure or how incomplete survey responses were handled. As a result, the endpoint’s definition is available, but its observed result and precision cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a binary primary outcome: a participant is counted as having a positive visual analog scale score if the score is > 50. The reported measure is a count of participants. In general, a binary endpoint reduces each participant’s outcome to one of two categories. This can make a result straightforward to describe, but it also discards information about the score’s location and variation within either category. The registry record does not report the observed count or the number of participants with an evaluable survey, so neither an observed proportion nor its uncertainty can be interpreted.

What does a confidence interval add?

In general, a confidence interval expresses the uncertainty associated with an estimated quantity, such as a participant proportion. It is not a guarantee about where a future study’s result will fall. Its width is influenced by the amount of information and the observed data, as well as by the method used to calculate it. No confidence interval or interval method for the primary outcome is reported in the registry record. Without the endpoint result and denominator, readers cannot assess how precise an estimated positive-score proportion would be.

What can a single-group result estimate?

In general, a single-group study can describe outcomes among the participants observed under its study conditions. A comparison requires a basis for distinguishing the outcome under one condition from the outcome under another. Here, the registry record identifies one lens-wear group and no comparator. Consequently, even if the primary result were reported, it would be a description of that group rather than a controlled estimate of a difference between lens options. Differences from an external benchmark or from participants’ past experience are not reported as formal comparisons in the record.

How should the planning illustration be understood?

The registry record describes a planning illustration based on a stated fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that non-time-to-event illustrations are expressed as participants per arm. These assumptions describe a hypothetical planning calculation, not the design actually used in this single-group study. The record does not report numerical planning results, and it does not report a trial-specific sample-size justification. The illustration should not be read as observed power or as evidence that the completed study was designed around a particular effect.

In general, power is a design concept concerning the chance that a planned analysis will detect a specified effect under specified assumptions. A post hoc calculation based on an observed effect does not show that a study had that chance of detecting an effect before data collection. Planning examples can help illustrate the consequences of assumptions, but they do not replace a documented prospective design rationale. No such rationale is reported in the registry record.

Why can extra variation matter?

In general, over-dispersion means that observed variability is greater than expected under a statistical model. When present, a model that assumes less variability than the data contain can understate uncertainty and make results appear more precise than warranted. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report an analysis model, model diagnostics, or an assessment of over-dispersion, so no conclusion about its presence or handling is possible for this study.

Likewise, the record does not report whether an unadjusted or adjusted analysis was intended, which statistical test was used, or whether any covariates were included. No inferential analysis is listed. These omissions mean that there is no registry-reported estimate or statistical test to interpret. General methods can explain how counts, proportions, and uncertainty are often assessed, but they cannot fill in an analysis that is not reported.

For the posted safety counts, the at-risk group size and affected count are stated for serious and other adverse events. In general, a count of zero is an observed count for the period and population represented in the record; it is not proof that the underlying event risk is zero. Interpretation depends on event definitions, observation time, completeness of follow-up, and reporting procedures. Those details are not reported in the registry record. No additional calculations or interval estimates are reported for these counts.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Lens Wear Experience")
n      <- c(25)
events <- c(22)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Lens Wear Experience  25  22  88.0  68.8  97.5  70.0  95.8  69.8  95.6

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures, but only the primary Visual Analog Scale outcome is described in the registry entries. The other measure’s definition, timing, and role in the analysis are not reported in the registry record. The record does not report whether the two outcomes were treated as separate confirmatory questions, whether one was considered exploratory, or whether any adjustment for multiple testing was planned.

In general, multiplicity arises when several statistical questions or tests are considered. If many tests are conducted, interpreting each one without regard to the others can increase the chance of a nominally notable result occurring by chance. Methods for addressing multiplicity depend on the aims and structure of the analyses. No multiplicity method or testing hierarchy is reported, so it is not possible to determine how this issue was handled.

The registry record does not report missing primary outcome data, the number of participants who completed the survey, or the method used to handle incomplete responses. It also does not report whether participants who stopped wearing lenses remained in the outcome assessment. In general, missingness can affect an estimated proportion when participants with missing data differ from those with observed data. The extent and direction of any such effect cannot be assessed without information on missing observations and the analysis approach.

Analysis populations are not described in the registry record. It does not state whether the primary analysis included all enrolled participants, only those who wore the lenses, or only those with a completed survey. No imputation method, sensitivity analysis, or participant flow for the endpoint is reported. Accordingly, the endpoint denominator and the treatment of missing data remain unknown.

12. 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.

For the Lens Wear Experience group, the registry record lists 35 participants at risk for serious adverse events and zero affected. It also lists 35 at risk for other adverse events and zero affected. Deaths are listed as zero. No serious adverse-event terms are listed among the top terms.

These figures are counts reported for the study group; they are not estimates from a comparison with another group. The zero affected counts mean that no affected participants are recorded in these registry fields. They do not show that the underlying possibility of an adverse event is zero. In general, the interpretation of safety counts also depends on how events were defined, collected, and followed over time. Apart from the listed figures, those procedures and the duration of safety observation are not reported in the registry record.

The at-risk count for these safety fields should not be assumed to be the denominator for the primary visual analog scale outcome. The primary endpoint denominator and observed result are not reported in the registry record. The safety counts therefore describe the posted adverse-event fields, not participants’ visual analog scale responses.

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

The record establishes that this completed study examined a daily disposable multifocal soft contact lens in presbyopic adults who had previously dropped out of contact lens wear. It describes daytime wear for about a month and defines the primary outcome as the count of participants with positive vision-symptom visual analog scale scores, where positive is defined as > 50. It also reports the enrollment and the listed adverse-event counts.

The record does not report the primary endpoint’s observed count or proportion. It therefore cannot show how many participants crossed the stated score threshold, how variable participants’ scores were, or how precise any estimated proportion might be. The description of an endpoint is not itself an outcome result. The record also does not report the other outcome’s details or an analysis of either outcome.

The single-group design means that any observed responses would characterize the lens-wear group in the study. Without a comparator, the record cannot establish a difference relative to another lens or another condition. The absence of masking, as recorded, is also relevant context when interpreting a participant-reported outcome, although the record does not report how participants’ expectations were assessed.

Zero affected participants in the posted serious and other adverse-event fields, and zero deaths, are the recorded safety counts. Those counts should be read as registry entries for this group, not as proof that no safety events could occur under other circumstances. The registry record does not report further details about safety monitoring or event collection.

In short, the record describes the study question and design but does not provide enough outcome information to characterize the primary endpoint statistically. It supports neither a conclusion about comparative effects nor a conclusion about the distribution or precision of symptom scores.

14. Why This Trial Matters Statistically

This study raises a statistical question common to studies of participant experience: how should a subjective score be summarized, and what information is needed to interpret that summary? The primary endpoint uses a defined threshold, which can produce a count of participants meeting a criterion. But a count is interpretable as a frequency only when the result and its denominator are reported. Neither is reported for the primary outcome in this registry record.

The record also illustrates the distinction between describing an outcome and estimating a comparative effect. A single-group design can describe the participants enrolled and their outcomes if those results are available. It does not create a concurrent reference group. As a result, a reader should not treat an outcome description or a planning illustration as evidence of a controlled difference between lens options.

Transparent reporting of endpoint results, denominators, missing observations, and analysis methods is important because those details determine what a numerical estimate means and how precisely it can be interpreted. The registry record identifies the endpoint’s threshold and timeframe, but does not report the endpoint result, its uncertainty, or the analysis population. The gap makes it impossible to evaluate the primary statistical finding from the registry record.

The listed safety counts offer a separate example of why numerical context matters. Counts of zero are useful to report, but their interpretation depends on who was observed, for how long, and under what event-collection procedures. Those details are not reported in the registry record. The study therefore matters statistically as an example of how design, outcome definition, and completeness of results jointly determine the conclusions that a record can support.

15. 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 primary limitation for statistical interpretation is that the registry record does not report the primary endpoint result. There is no observed number of participants with visual analog scale scores > 50, no endpoint denominator, and no confidence interval. Enrollment of 35 does not establish that all enrolled participants contributed primary outcome data.

The single-group design has no separate comparator, and masking is listed as none. The study therefore does not provide a randomized contrast, and participant-reported outcomes may be interpreted in the context of an unmasked study. The registry record does not describe any steps to assess or address expectations or other potential influences on survey responses.

Details needed to assess the population and conduct are also limited. The record does not report detailed eligibility criteria, the number who completed the intended wear period, participant flow, or the handling of incomplete survey responses. It does not give the other outcome’s definition, a statistical analysis plan, an analysis population, or a trial-specific sample-size justification. The planning illustration described in the record is not the study’s own design rationale.

For safety, the registry lists 35 participants at risk and zero affected for both serious and other adverse events, with zero deaths. It does not report further details about event definitions, collection, or observation time. Those limits constrain interpretation of the safety counts as well as the primary endpoint. The registry record supports description of the recorded design and counts, but not a complete assessment of outcome precision, missing data, or comparative effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers — NCT06053463.
• Registry record last updated 2024-11-27; status last verified 2024-11.
• Results first posted 2024-11-27.
• 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.

19. Record Summary

NCT06053463 is a completed, single-group study of daily disposable multifocal soft contact lenses in presbyopic adults who had previously dropped out of contact lens wear. The registry record lists enrollment of 35, no masking, and allocation as NA. Participants were to wear lenses during the day for about a month. The listed start date is 2023-10-06, and the listed primary completion date is 2024-05-23.

The primary outcome is a Visual Analog Scale survey of vision symptoms at 1 month, defined by a positive score of > 50 and recorded as a participant count. The observed primary outcome and its denominator are not reported in the registry record. Two outcome measures are listed, but details of the other measure are not reported in the registry record. No analysis is listed.

The Lens Wear Experience group has 35 participants listed at risk and zero affected for serious adverse events, 35 at risk and zero affected for other adverse events, and zero deaths. These are the posted safety counts; further event-collection details are not reported in the registry record.