CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation (NCT02147093), a randomized na study. The primary outcome is Distance LogMAR Visual Acuity.

2. Clinical Question

In plain terms, the clinical question is whether the recorded distance visual acuity differed between the multifocal correction and the sphere correction used with near vision spectacles. The randomized crossover format means that the registry describes participants moving through correction conditions in different orders, rather than simply comparing separate groups that each received only one correction. That structure can make within-participant comparisons relevant, but it does not by itself establish what comparison was used in the analysis or whether order and period effects were considered.

The endpoint population is restricted by completion of study visits and absence of a major protocol deviation. The record does not state how that population was handled in the statistical analysis, and no numerical endpoint analysis is reported. The question can therefore be described from the protocol fields, but its answer cannot be inferred from the endpoint definition or the trial design alone.

3. Trial Design

The registry identifies CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation as a completed, randomized crossover device study. Its listed phase is NA. The sponsor is Johnson & Johnson Vision Care, Inc. Enrollment is recorded as 41. The study start is 2014-05-01 and primary completion is 2014-08-01. These record details describe conduct and status; they do not supply the clinical outcome findings.

Two correction conditions are named: Test (multi-focal) and Control (Sphere). The model is crossover and masking is listed as none. The arm descriptions give two sequences. In the control-first sequence, subjects first used the control sphere lens with reading glasses for one week, then used the test multifocal lens for one week. In the other sequence, subjects first used the test multifocal lens for one week, then used the control sphere lens and a pair of reading glasses for one week. The sequence labels in the record are not entirely consistent with the descriptions, so the descriptions of the periods are the clearest account of the order.

Randomization indicates that assignment to sequence was randomized, but the method used to generate or conceal that assignment is not reported in the registry record. Because masking is listed as none, the registry does not describe masking of participants or study personnel. More detailed information about washout, visit scheduling, adherence, lens fitting, or handling of period and sequence effects is not reported in the registry record.

The crossover format is important when interpreting the planned comparison. In general, a crossover trial can compare measurements from the same participant under different conditions, while the order of conditions may also matter. The record establishes that conditions were used in a sequence, but does not report the statistical approach used to account for this structure. No specific primary analysis, model, or effect estimate is reported. Accordingly, design information supports a description of the comparison, but not a numerical conclusion about visual acuity.

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.

Period 1

Reasons for not completing this period:

Period 2

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All subjects that completed all study visits 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 that were randomized to one of two lens wear serquences.

6. Primary Endpoint

The registry lists the primary outcome as Distance LogMAR Visual Acuity, measured over 7 days post wear.

The primary endpoint is distance LogMAR visual acuity, reported as a mean with standard deviation. LogMAR is a logarithmic measure of visual acuity: it expresses performance on a scale that supports quantitative comparison across measurements. In general, continuous outcomes such as this can be summarized by a mean to describe the central level of the measured result, with a standard deviation to describe the spread of individual observations around that mean.

The registry specifies a timeframe of 7 days post wear. Testing was binocularly at 4m, under 250 cd/m^2 and 2.5 cd/m^2 luminance. The listed conditions include high luminance with high contrast (90%) and low contrast (10%), and low luminance with high contrast (90%). These conditions indicate that the endpoint assessment covered more than one viewing condition; the registry record does not provide category-specific numerical results or state how the measures across conditions were combined for a single comparison.

Distance visual acuity is used to quantify the clarity of distance vision under defined test conditions. The endpoint can therefore address a specific aspect of visual performance, but does not by itself capture every aspect of lens performance or acceptance. The record lists two outcome measures, and the primary measure’s description identifies visual acuity rather than a broader measure of satisfaction or daily function. Without the posted outcome values, mean difference, or uncertainty interval, the endpoint definition explains what was measured but not what the comparison found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a continuous measure summarized by a mean and standard deviation. In general, a mean gives a central summary on the measured scale, while a standard deviation describes the variability of observations around that mean. These summaries can help readers understand both the average result and the spread of results, but they do not alone establish the difference between treatment conditions or the precision of that difference. The registry does not provide the numerical summaries for this endpoint.

How does a crossover comparison work?

In general, a crossover design exposes participants to more than one condition in a planned order. It can use each participant’s measurements under the different conditions to assess the contrast, which may account for stable differences between people. However, measurements can also be influenced by period, sequence, carryover, or changes over time. A suitable analysis needs to reflect the design and the estimand—the precise contrast the study intends to estimate. The registry describes randomized sequences and one-week periods, but the statistical model and handling of these design features are not reported in the registry record.

Randomization is a design method intended to reduce systematic differences between assigned sequences. The record identifies the study as randomized but does not describe the sequence-generation method or concealment process. Masking is listed as none. In general, lack of masking can affect subjective assessments or participant and assessor behavior; the relevance depends on the measure and conduct of the study. The record does not describe further safeguards or how measurement personnel were involved.

What do uncertainty measures contribute?

For a continuous outcome, an estimated contrast and its confidence interval would be useful for interpreting the comparison. The contrast expresses the estimated difference under a stated analysis, while the interval communicates uncertainty around that estimate. A p-value, if reported, addresses compatibility of the observed data with a specified null hypothesis under assumptions; it does not measure the size or importance of an effect. No estimate, confidence interval, or p-value for the primary endpoint is reported in the registry record. Therefore, none of these statistical quantities can be interpreted for this trial from the registry information.

Assumptions also shape statistical inference. For example, an analysis may rely on distributional assumptions, independence or dependence structures, and a specified model for repeated measurements. In general, those assumptions should fit the design and outcome. Since the record does not report the outcome analysis method, it is not possible to assess its assumptions, model fit, or treatment of repeated observations. No recalculated effect estimate is presented.

What is the role of the planning illustration?

The registry’s sample-size assumptions describe a planning illustration computed from the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are stated planning assumptions, not a report of the trial’s design justification. The record does not report the original sample-size justification, and no numerical planning outputs are included in the registry record described for this analysis.

In general, a sample-size illustration asks how many participants per arm might be needed under specified assumptions to detect an effect at a selected power. Such an illustration is conditional on the chosen effect, variability, allocation, and model assumptions. It is not observed power and does not describe the probability that the completed study has established a true effect. Here, the registry does not report a numerical observed effect for the primary endpoint, so the illustration cannot be used to infer the result or its precision.

The registry lists 2 outcome measures and 0 analyses. That entry does not provide analysis details or numerical endpoint results. The primary outcome description names the mean and standard deviation as parameters, but does not establish that a particular model was fitted or that a particular contrast was tested. The record also does not report whether the primary comparison was adjusted, whether results were analyzed by sequence, or whether any sensitivity analysis was carried out. Those methods should not be inferred from the design labels alone.

For this endpoint, the registry identifies a restricted analysis population: subjects completing all study visits without a major protocol deviation. In general, restricting analysis to completers can produce a population different from all randomized participants if completion or protocol deviations are related to participant characteristics or outcomes. That is a general methodological concern, not evidence that such bias occurred in this trial. The record does not report participant flow, reasons for missing measurements, or the methods used to address incomplete data, so the impact cannot be assessed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures, but the information available does not specify how multiple outcomes, visual acuity conditions, or comparisons were handled in the statistical analysis. A multiplicity strategy—such as defining a hierarchy or adjusting inference across several tests—can affect how evidence is interpreted when multiple hypotheses are examined. Whether such a strategy was used is not reported in the registry record. No adjustment should be assumed, and no unadjusted or adjusted test result is reported for the primary outcome.

The primary endpoint description includes different luminance and contrast conditions. The record does not state whether each condition was treated as a separate outcome, whether one condition was designated as the main comparison, or whether results were combined. It also does not report a statistical plan describing the relationship between the listed outcome measures and the primary comparison. Consequently, the multiplicity implications cannot be evaluated from the registry fields alone.

Missing-data handling is also not reported in the registry record. The endpoint population is defined by completion of all study visits without a major protocol deviation, but the record does not give the number of participants included in that population, the amount or pattern of missing endpoint data, or any imputation or sensitivity-analysis method. The reasons for missing data and deviations are not reported.

In general, missingness can affect an estimate when the availability of measurements is related to the outcome or to factors associated with it. A complete-visit population may be appropriate for a particular estimand, but its interpretation depends on the study question and analysis plan. No such rationale or estimand details are reported. Thus, neither the potential effect of missing data nor the robustness of the endpoint findings can be judged from the registry record.

11. Safety Results

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

Other (non-serious) adverse events

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

For Control (Filcon II 3-sphere), the registry reports 40 at risk and 0 affected for serious adverse events, and 40 at risk and 0 affected for other adverse events. For Test (Filcon II 3-multi-focal), it likewise reports 40 at risk and 0 affected for serious adverse events, and 40 at risk and 0 affected for other adverse events. These are the posted group-level safety counts; they do not provide detail about the timing, duration, or nature of individual events.

The serious adverse event terms list is empty. Death counts are not reported in the registry record; a missing death count should not be read as a recorded zero. The at-risk counts are reported separately for the correction groups. Because the study is crossover, those group counts should not be added or treated as a count of distinct participants.

Zero affected in these registry fields means that no affected count is recorded for the listed categories in the stated groups. It does not establish that an event is impossible, that every event was captured, or that the corrections have equivalent safety. Safety counts also do not answer the primary visual acuity question. Interpretation is limited to the categories and counts recorded, without additional event-level information or a reported comparative safety analysis.

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

The registry record establishes that a randomized crossover evaluation compared a multifocal contact lens correction with a sphere contact lens correction used with reading glasses. It identifies distance LogMAR visual acuity as the primary outcome and describes the conditions and timing of its assessment. Those details make the intended research question understandable, but they do not supply the outcome values needed to answer it.

Because the numerical primary results are not reported in the registry record, no statement can be made about whether mean visual acuity differed between conditions, which condition had the higher mean, or how large any difference was. The record also does not report an uncertainty interval or test result. It is therefore not possible to assess the precision of a comparison or distinguish a small, uncertain estimate from a larger, more precisely estimated one.

The endpoint is a measure of distance visual acuity under specified test conditions. Even if numerical results were available, that endpoint would describe performance on the measured scale rather than every aspect of lens acceptance, comfort, near vision, or day-to-day use. The brief summary mentions performance and acceptance, but the primary outcome identified in this record is visual acuity. Broader conclusions would require corresponding outcome definitions and results, which are not reported in the registry record.

The safety fields report zero affected counts for the listed serious and other adverse-event categories in each group, with 40 at risk in each. These entries describe recorded counts, not proof of no risk or a formal demonstration of equivalent safety. They should remain separate from interpretation of the efficacy endpoint.

Overall, the record supports a description of the design, comparison, measurement, and reported safety counts. It does not support a conclusion that either correction improved, worsened, or matched the other on distance visual acuity. That distinction is important: a clearly described study question is not itself evidence about the answer.

13. Why This Trial Matters Statistically

This trial is statistically notable for its crossover structure and its use of a continuous visual acuity endpoint. A crossover design can make within-participant contrasts possible, but only if the analysis and interpretation account for the repeated conditions and their order. The registry describes randomized sequences and one-week use periods, while leaving the analysis method unreported. That gap illustrates why design labels alone are not enough to evaluate an estimated treatment contrast.

The endpoint also illustrates the difference between knowing what was measured and knowing what was found. The record gives a LogMAR measure, specifies binocular testing, identifies distance testing at 4m, and lists luminance and contrast conditions. Yet it does not report the numerical mean, standard deviation, or comparative estimate. Without those, neither effect size nor precision can be assessed. Statistical interpretation requires the actual results and their uncertainty, not only the measurement definition.

The restricted endpoint population raises another general issue: an analysis of participants who complete all visits without major protocol deviations may differ in interpretation from an analysis based on all randomized participants. The record does not explain how that population was implemented or how incomplete observations were treated. This makes it difficult to judge the target population represented by any intended estimate.

Finally, the separate safety counts demonstrate why endpoints should not be conflated. Recorded affected counts for adverse-event categories do not answer a visual acuity question, just as an acuity comparison would not by itself establish safety or acceptance. The record is useful for clarifying those distinctions, even though its missing numerical primary findings prevent assessment of the central comparison.

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 interpreting this trial is that numerical results for the primary visual acuity endpoint are not reported in the registry record. The mean and standard deviation are identified as the planned summaries, but the values, comparative estimate, confidence interval, and test result are absent. The direction, magnitude, and precision of the primary comparison therefore cannot be assessed.

The registry gives the endpoint population definition but does not report how many participants were analyzed under that definition, how participant flow proceeded, or why any measurements may have been unavailable. Missing-data methods and sensitivity analyses are not reported. This limits assessment of whether the analysis population reflects the randomized sequences and how incomplete visits or protocol deviations may have affected interpretation.

Although the study is described as randomized and crossover, details about the randomization procedure, allocation concealment, washout, period effects, carryover, and the primary statistical model are not reported in the registry record. Masking is listed as none, but further information about outcome assessment is not reported. It is therefore not possible to determine how the analysis addressed repeated measurements or potential order effects.

The endpoint description includes multiple luminance and contrast conditions, while the record does not explain how those conditions related to the primary comparison or how multiplicity was handled. The registry lists 2 outcome measures and 0 analyses, but does not give a statistical analysis plan or numerical outcome findings. The original sample-size justification is not reported in the registry record; the described planning assumptions do not replace that information.

Safety reporting is limited to group-level at-risk and affected counts. Event descriptions beyond the empty serious-event term list, death counts, timing, and a comparative safety analysis are not reported. These limitations constrain interpretation of the record; they do not establish that an unreported procedure or result was absent from the trial itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation — NCT02147093.
• Registry record last updated 2018-06-19; status last verified 2017-06.
• Results first posted 2016-07-20.
• 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 completed study is a randomized crossover device evaluation of multifocal and sphere contact lens corrections for presbyopia. Enrollment is recorded as 41. The study start is 2014-05-01 and primary completion is 2014-08-01. Masking is listed as none, and the phase is NA.

The primary outcome is distance LogMAR visual acuity, reported as a mean and standard deviation, with a timeframe of 7 days post wear. Testing is described as binocular at 4m under specified luminance and contrast conditions. The endpoint population is subjects who completed all study visits without a major protocol deviation. Numerical primary outcome results and the analysis method are not reported in the registry record.

For each correction group, the registry records 40 at risk and 0 affected for serious adverse events, and 40 at risk and 0 affected for other adverse events. Death counts are not reported in the registry record. The available record describes the question and design, but does not report enough numerical outcome information to interpret the primary visual acuity comparison.