Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses (NCT04974697), a na na study. The primary outcome is Overall Vision.

2. Clinical Question

In statistical terms, this is a question about the reported experience of participants using an investigational lens, not a controlled estimate of how that lens compares with another product. The registry record identifies the lens and the outcome but does not report a numerical primary estimate, confidence interval, or test result. It therefore does not establish how far the reported vision score was from a baseline value or from a comparison group. The study description mentions a baseline assessment and a staged dispensing process; the exact timing and analysis details for every outcome are not reported in the registry record.

3. Trial Design

The registry record describes a completed, single-group device study of the JJVC Investigational Multifocal Toric Contact Lens. Enrollment is listed as 95. The study started on 2021-07-19, and primary completion is listed as 2021-10-29. The phase and allocation fields are marked NA. The record identifies Johnson & Johnson Vision Care, Inc. as the sponsor.

The brief summary describes a bilateral, single-masked, single-arm, 4-visit dispensing study. Participants were to receive lenses for 6 to 8 days, have lens power optimized if necessary, and then receive lenses for a further 2 weeks for assessment of clinical performance. The design fields separately list masking as NONE. These descriptions do not agree, and the registry record does not explain the difference. The masking status should therefore be treated as unclear rather than resolved by assumption.

The arm description says eligible subjects who were adapted contact-lens wearers with presbyopia, ametropia, and astigmatism would be dispensed the study lens bilaterally. There is no separate control arm in the record. Because the study is single-group and allocation is NA, its design does not support a randomized between-group comparison. Any within-participant change would also require a clearly specified baseline, analysis population, and handling of missing observations to interpret fully; those details are not reported in the registry record.

The primary endpoint is identified as overall vision at 2-Week Follow-up. The record also lists change from baseline in CLUE Vision, Comfort, and Handling scores as secondary outcomes. It records 5 outcome measures and 11 analyses, but the additional outcome details and the planned statistical methods for those analyses are not reported in the registry record. The status is COMPLETED, which describes trial status; it does not by itself establish that every planned assessment was collected or analyzed.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Subjects that completed the study without a major protocol deviation.

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 dispensed a study lens.

6. Primary Endpoint

The registry lists the primary outcome as Overall Vision, measured over 2-Week Follow-up.

Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. The record describes CLUE as a validated patient-reported outcomes questionnaire for assessing soft contact-lens experience, including comfort, vision, handling, and packaging, among contact-lens wearers in the US ages 18-65. The recorded primary measure is the mean score for overall vision, with standard deviation as the dispersion measure, at 2-Week Follow-up.

CLUE scores are derived using Item Response Theory and are described as following a normal distribution. The registry record gives a population average score of 60, a standard deviation of 20, and a range of 0-120. Higher scores indicate a more favorable or positive response. These properties help explain the scale: the score represents a standardized patient-reported experience rather than a direct measurement of visual acuity in a clinical test.

A mean describes the central score for the analyzed population, while the standard deviation describes how much individual scores vary around that mean. Neither statistic alone shows how precisely the mean has been estimated; a confidence interval would help express that uncertainty, but one is not reported in the registry record. The primary analysis population is specified as subjects who completed the study without a major protocol deviation. The numerical mean and standard deviation for the primary endpoint are not reported in the registry record, so the recorded scale description cannot be used to infer the study's observed result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean describe?

The primary measure is a mean, a summary of the central score in the analysis population. For a continuous outcome such as a questionnaire score, the mean provides a compact description of participants' responses. It does not show whether individual scores were similar or widely dispersed. The record specifies standard deviation as the measure of dispersion. Standard deviation describes variation among scores around the mean; it is not the same as uncertainty in the mean itself.

For the CLUE scale, higher values are described as more favorable or positive. That direction helps interpret a score when an actual result is reported, but it does not supply the study's result. The registry record gives scale characteristics, including the population average score of 60, standard deviation of 20, and score range of 0-120. Those are scale-level reference details, not the trial's observed mean or standard deviation.

What would a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimated quantity. It gives a range of values compatible with the data and the method used, rather than presenting only a point estimate. Its width depends on factors such as the amount of information in the analysis and the variability of the outcome. A narrow interval indicates greater precision than a wide interval, although precision does not establish that an estimate is free from bias or that it is clinically important.

No confidence interval for the primary outcome is reported in the registry record. Without the endpoint estimate and its uncertainty, readers cannot judge how precisely the overall-vision mean was estimated. A p-value, if reported, would address a different question about compatibility with a specified null model; it would not replace the estimate, its uncertainty, or the limitations of a single-group design. No primary p-value is reported in the registry record.

Why does the analysis population matter?

The listed primary population consists of subjects who completed the study without a major protocol deviation. An analysis restricted by completion and protocol adherence may differ from an analysis that includes everyone enrolled or all participants who started treatment. If completion or deviations are related to participants' outcomes, the analyzed group may not represent the full enrolled group. The registry record does not report the number analyzed, the participant flow, the reasons for deviations, or a separate analysis population intended to address these issues.

Missing observations can affect both the estimated mean and its precision. In general, the consequences depend on why observations are missing and on the methods used to handle them. An analysis of only observed scores can be misleading if the people with missing scores differ systematically from those with recorded scores. The missing-data approach is not reported in the registry record, so its potential influence cannot be assessed.

What can a single-group design estimate?

A single-group study can describe outcomes observed among participants using the study lens. Without a comparator, however, it cannot distinguish changes associated with lens use from changes that might also occur without the study lens. Expectations, adaptation, time, co-interventions, and lens-power adjustment can be relevant in general to interpretation of a before-and-after measurement. The registry record does not document a controlled comparison that would separate these influences.

The study description indicates bilateral dispensing and possible lens-power optimization. Those features describe the intervention process, but they do not create an independent control condition. The record's allocation field is NA and its model is SINGLE GROUP. Any interpretation should therefore remain descriptive rather than treating an observed change as a randomized treatment effect.

How should the planning calculations be understood?

The stated planning assumptions describe an illustrative sample-size calculation based on an observed effect, not the trial's own design. The calculation assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers detecting a stated fraction of the observed effect. Since the trial is recorded as single-group, the assumed two-arm setting does not mirror the study design.

In general, sample-size planning asks how much information a proposed design would need to detect a specified effect under stated assumptions. Changing the target effect changes the planning requirement, and the result also depends on variability and the chosen error rate. Such a calculation is not a measure of what the completed study actually achieved. It is not observed power, and it does not establish that the study was adequately planned or that its result is precise. The registry record does not report the protocol's sample-size justification. The observed primary effect required to interpret the planning illustration is also not reported in the registry record.

What do the outcome and analysis counts establish?

The record lists 5 outcome measures and 11 analyses. Those counts indicate that multiple outcomes or analyses are recorded, but do not identify every analysis method, its role, or whether it was prespecified. The listed secondary outcomes include change from baseline in CLUE Vision, CLUE Comfort, and CLUE Handling scores. The multiplicity strategy, if any, is not reported in the registry record. When multiple outcomes or tests are considered, general statistical practice recognizes that the chance of at least one apparently notable result can rise unless the analysis plan accounts for multiplicity. The record does not allow assessment of how that issue was handled.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 5 outcome measures and 11 analyses. It identifies change from baseline in CLUE Vision Score, CLUE Comfort Score, and CLUE Handling Score as secondary outcomes, in addition to the primary overall-vision outcome. Details for all remaining recorded measures and analyses are not reported in the registry record. A multiplicity adjustment or hierarchy among outcomes is not reported, so it is not possible to determine whether the analyses were treated as confirmatory, exploratory, or otherwise related.

In general, testing multiple outcomes can increase the chance of finding at least one apparently unusual result by chance. Methods such as prespecifying a primary endpoint, adjusting significance thresholds, or describing secondary analyses as exploratory can help clarify the intended interpretation. Which approach was planned or used is not reported in the registry record. The absence of that information does not show that no method was used; it means the record does not permit its evaluation.

The primary population is defined as subjects who completed the study without a major protocol deviation. The number included, missing outcome counts, reasons for missingness, handling of incomplete questionnaires, and any sensitivity analyses are not reported in the registry record. The record also does not report whether other analysis populations were used. These omissions limit assessment of possible selection or missing-data effects and make it difficult to connect the stated analysis population to the listed enrollment.

11. 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 record lists 86 participants at risk and 0 participants affected in the Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker group. It lists 0 deaths. For other adverse events, the record also lists 86 participants at risk and 0 participants affected. No top serious-event terms are listed.

These figures describe what the registry record reports for the specified safety categories. A count of 0 affected means no affected participants are recorded in that category; it does not establish that an intervention has no risks. The figures also do not describe the frequency or severity of every possible symptom unless those events were included and reported in the record. The registry record does not provide further detail on event definitions, observation time for safety, or collection procedures.

The safety group label names a lens formulation and is not identical to the general intervention name used in the study description. The record does not explain that naming difference. The figures should be read as registry-recorded safety counts, not as a comparison with another lens, because no comparator group is recorded.

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

The registry record describes a completed evaluation of an investigational multifocal toric contact lens in a single-group, bilateral dispensing study. It identifies overall vision on the CLUE questionnaire as the primary outcome at 2-Week Follow-up and defines a primary analysis population of study completers without a major protocol deviation. It also records secondary CLUE outcomes and safety counts.

However, the numerical primary outcome is not reported in the registry record. There is no reported study mean or standard deviation for overall vision, and no confidence interval or p-value for that endpoint. As a result, the record does not allow readers to determine the observed score, its variability, or the precision of the estimate. The scale's population average and range describe the questionnaire, not the trial's outcome.

The design also limits what could be concluded even if a within-group change were reported. With no recorded comparator, a change over time could not be attributed uniquely to the lens. The record does not document a randomized comparison, and allocation is listed as NA. The possible lens-power optimization described in the study summary adds context to the dispensing process but does not supply a control condition.

The safety record reports 0 affected participants for serious adverse events and 0 for other adverse events among 86 at risk, with 0 deaths. These are the recorded counts for the stated categories, not proof that no adverse effects occurred or that risk is absent. The record's brief safety summary does not support broader claims beyond those categories and counts.

Accordingly, the registry record provides useful information about the question, measurement, and study structure, but it does not provide the primary numerical result needed to assess the observed vision score. It also does not support a comparative or causal conclusion. Neither the completed status nor the descriptive scale information fills those gaps.

13. Why This Trial Matters Statistically

This study illustrates why interpreting a clinical outcome requires more than knowing the name of the endpoint. The CLUE overall-vision score is a patient-reported measure with a stated direction and scale range, and the registry record identifies its assessment timeframe and summary statistic. Those details clarify what was intended to be measured. Without the study's numerical estimate and its uncertainty, however, the outcome cannot be quantitatively interpreted.

The design is equally important. A bilateral, single-group study can document the experience of participants using a lens under the study's dispensing process. It does not furnish a concurrent control for separating that experience from changes over time, expectations, or other influences. This distinction applies regardless of whether the outcome is reported as a mean, a change from baseline, or another summary.

The record also shows why analysis populations and missing data deserve attention. The primary endpoint population excludes subjects who did not complete the study without a major protocol deviation. The number analyzed and the missing-data approach are not reported in the registry record. Readers therefore cannot assess how that restriction relates to enrollment or whether incomplete observations could have affected the result.

Finally, the record includes multiple outcome measures and analyses, but does not report a multiplicity strategy. That information matters when interpreting a collection of statistical findings, because isolated results can be difficult to distinguish from chance findings without a clear analysis plan. Taken together, the record is useful for understanding the intended measurement and study structure while also demonstrating the limits imposed by an unreported primary estimate and incomplete statistical detail.

14. 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 main limitation for statistical interpretation is that the registry record does not report a numerical primary outcome. The mean and standard deviation for overall vision, as well as a confidence interval and test result, are not reported. Without them, the observed level, variability, and precision cannot be assessed. The scale's reference characteristics do not resolve this limitation.

The primary population is restricted to subjects who completed the study without a major protocol deviation. The number analyzed, participant flow, reasons for noncompletion or deviations, and characteristics of any excluded participants are not reported in the registry record. The missing-data method and any sensitivity analysis are also not reported. These omissions limit assessment of whether the analyzed participants adequately represent those enrolled.

The study is recorded as single-group with allocation marked NA and no comparator. This limits comparative and causal interpretation. The brief summary calls the study single-masked, while the masking field is NONE; the registry record does not reconcile this difference. The timing of baseline assessments relative to dispensing and lens-power optimization is not reported in enough detail to resolve how each endpoint should be aligned with the study process.

The record lists 5 outcome measures and 11 analyses, but a full analysis plan and any multiplicity strategy are not reported. The protocol's sample-size justification, interim analyses, and statistical plan are not reported in the registry record. Planning calculations based on an observed effect are described as illustrations and assume a two-arm setting, which differs from the recorded single-group study. These limitations mean the record supports a description of the design and intended measures, but not a full evaluation of the statistical evidence for the primary outcome.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses — NCT04974697.
• Registry record last updated 2022-11-14; status last verified 2022-10.
• Results first posted 2022-11-14.
• 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.

18. Record Summary

The registry record describes NCT04974697, Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses, as a completed, single-group device study sponsored by Johnson & Johnson Vision Care, Inc. Enrollment is listed as 95. The study started on 2021-07-19, and primary completion is listed as 2021-10-29.

The primary outcome is overall vision measured by the CLUE questionnaire at 2-Week Follow-up, summarized as a mean with standard deviation among subjects who completed the study without a major protocol deviation. Secondary outcomes include change from baseline in CLUE Vision, Comfort, and Handling scores. The brief summary describes bilateral dispensing, possible lens-power optimization, and a further 2 weeks of lens use after an initial 6 to 8 days.

The registry record does not report the numerical primary outcome or its uncertainty. It lists no comparator group, and the masking descriptions conflict. Serious and other adverse-event counts each list 86 at risk and 0 affected, with 0 deaths. Additional analysis details, missing-data handling, and a multiplicity strategy are not reported in the registry record.