This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses (NCT03755882), a randomized na study. The primary outcome is Visual Performance.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03755882 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 46 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Female habitual reusable soft cosmetic contact lens wearers between the ages of 18 to 29 years were eligible for the study. The primary-outcome population is described as all subjects who successfully completed all visits. The registry record does not report how many subjects completed all visits or provide further characteristics of that population.
Intervention
One study lens was ACUVUE® DEFINE™ Vivid Style. Participants wore each lens type for approximately 2 weeks, following randomization to one of two lens-wear sequences.
Comparator
The other study lens was LACELLE™ Sparkling Brown. The record labels the groups Test (Etafilcon A) and Control (Hefilcon A), but does not explicitly map those material labels to the two intervention names in the listed intervention descriptions.
Primary question
The study aimed to compare monocular visual performance, measured in logMAR units, under three combinations of luminance and contrast while wearing the study lenses. The registry record does not report a numerical result or a statistical comparison of the lenses for these conditions.
3. Trial Design
This was a randomized, single-masked, 2×2 crossover study. The brief summary describes a 4-visit, multi-site, bilateral study in which eligible subjects were assigned to one of two lens-wear sequences. Each lens type was worn for approximately 2 weeks. The sequence labels in the record are Test/Control and Control/Test.
A crossover design means that participants receive both study conditions in a planned order, rather than remaining in only one condition throughout the study. In general, this allows a comparison to draw on measurements made in the same participant under each condition. Interpretation can depend on how the analysis accounts for the order and timing of measurements, and on whether effects of one period could carry into another. The registry record does not report details of any washout interval or a statistical method for handling period, sequence, or carryover effects.
The record describes the eligible subjects as female habitual reusable soft cosmetic contact lens wearers between the ages of 18 to 29 years. The primary-outcome population is defined as all subjects who successfully completed all visits. Enrollment was 46. The record reports the study as completed, with a start date of 2018-11-05 and a primary completion date of 2018-12-26. It names Johnson & Johnson Vision Care, Inc. as the sponsor.
The registry record does not report the number of subjects who completed all visits, the number assigned to each sequence, or further participant characteristics. It also does not report the identity of the masked party or parties beyond the description of the study as brand-masked and single-masked.
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
| Stage | Test/Control | Control/Test |
|---|---|---|
| STARTED | 23 | 22 |
| COMPLETED | 19 | 22 |
| NOT COMPLETED | 4 | 0 |
Reasons for not completing this period:
| Reason | Test/Control | Control/Test |
|---|---|---|
| Protocol Violation | 1 | 0 |
| Unsatisfactory Lens Fitting Test Article | 3 | 0 |
Period 2
| Stage | Test/Control | Control/Test |
|---|---|---|
| STARTED | 19 | 22 |
| COMPLETED | 19 | 22 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All subjects who had successfully completed all visits.
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.
| Characteristic | Unit | Total |
|---|---|---|
| Participants analysed | 45 | |
| Age, Continuous | years | 23.6 (SD 2.80) |
| Sex: Female, Male: Female | Participants | 45 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 45 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: China | Participants | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Performance, measured over Up to 2-Week Follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | logMAR Units |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Visual Performance and is a mean of a continuous measure, expressed in logMAR units. Monocular visual performance was assessed under three conditions: high luminance and high contrast; high luminance and low contrast; and low luminance and high contrast with distance goggles. Testing was conducted at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were used to calculate a visual performance score for each chart read.
The record explains that logMAR scores closer to zero, or below zero, indicate better visual acuity. It also states that a logMAR score of 0.0 is equivalent to Snellen visual acuity of 20/20. These features make the measure a way to describe visual performance on a scale that can be summarized numerically and compared across the lens-wear conditions.
As a general statistical point, reporting a mean describes the average measurement in the analyzed population, while a standard deviation describes the spread of individual measurements around that average. The registry record identifies standard deviation as the dispersion measure. It does not report the actual means or standard deviations for the lens conditions, so the direction and precision of any observed difference cannot be assessed from the record.
The stated timeframe is Up to 2-Week Follow-up. The primary-outcome population is all subjects who successfully completed all visits. The record does not report a single consolidated comparison across the three measurement conditions.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a randomized crossover comparison of ACUVUE® DEFINE™ Vivid Style and LACELLE™ Sparkling Brown, with visual performance assessed under three luminance-and-contrast conditions. It supplies the endpoint definition and identifies the intended primary-outcome population, but it does not provide the numerical outcome results. In particular, the registry record does not report condition-specific means, standard deviations, differences between lenses, confidence intervals, or p-values.
Without those results, it is not possible to describe which lens had a higher or lower mean visual-performance score, how large any difference was, or how precisely it was estimated. The record also does not report an analysis comparing the lenses. It therefore does not support an inference about statistical evidence for a difference in visual performance. This is a limitation of the information reported in the registry, not evidence that the lenses produced the same measurements.
The endpoint has three measurement conditions, and the record notes that it was not reduced to one comparison. Results for one condition would not automatically describe the other conditions. A reader would need condition-specific estimates and a clear account of the planned comparisons to understand whether any observed pattern was consistent across conditions. Those details are not reported in the registry record.
Because the study used a crossover design, interpretation also depends on how measurements from the two periods and the randomized sequences were handled. The registry record does not report the analysis method, including whether it accounted for period or sequence effects. No assumptions about those methods should be made from the design description alone.
Planning illustrations based on an observed effect are described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations are not observed power and do not substitute for the trial's outcome analysis. The registry record does not report numerical planning results or a sample-size justification for the trial itself.
In short, the record establishes what was intended to be measured and how the lens sequence was organized, but does not provide enough outcome or analysis information to quantify the comparison. A completed-study status and a stated enrollment do not, by themselves, establish the magnitude, precision, or statistical significance of an endpoint result.
9. Statistical Methods Explained
The methods description supports a limited account of the planned measurement and design. It identifies a randomized, single-masked crossover study and describes the endpoint as a mean continuous measure with standard deviation. It does not describe the statistical analysis actually used. The explanations below distinguish general statistical concepts from methods documented in the registry record.
What does a crossover design mean?
In general, a crossover design has participants receive more than one study condition in a planned sequence. This can make comparisons more efficient because measurements under the conditions can be obtained from the same participant. The study description says that eligible subjects were randomized to one of two lens-wear sequences and that each lens type was worn for approximately 2 weeks. The sequence labels are Test/Control and Control/Test.
The design alone does not establish how the comparison was analyzed. A suitable analysis may need to consider the repeated measurements within a participant and the timing or order of the conditions. Whether this trial used a particular model or adjustment is not reported in the registry record. Details of washout, period effects, sequence effects, and carryover are also not reported in the registry record.
What does the endpoint scale represent?
The endpoint is visual performance measured in logMAR units from ETDRS chart readings. The record describes letter-by-letter scoring and says that scores closer to zero, or below zero, indicate better visual acuity; it also gives 0.0 as equivalent to Snellen 20/20. The endpoint is recorded under three combinations of luminance and contrast. These conditions represent distinct testing settings, so a result for one setting should not be taken as a result for all settings.
A mean is a summary of the average measurement in the analyzed group or condition. A standard deviation describes the variability of observations around the mean. Neither measure alone gives the uncertainty in a comparison between lenses. For that, an analysis would generally report an estimated contrast between conditions and a measure of its uncertainty, such as a confidence interval. The actual means, standard deviations, contrasts, and confidence intervals are not reported in the registry record.
How should a confidence interval be understood?
In general, a confidence interval describes statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates a more precise estimate, while a wider interval indicates less precision. Its interpretation depends on the study design, analysis method, and data. No confidence interval for the lens comparison is reported in the registry record, so the precision of the estimated effect cannot be evaluated.
What does a p-value contribute?
In general, a p-value assesses how compatible the observed data are with a specified statistical null model, under the assumptions used to calculate it. It does not measure the size or practical importance of an effect, and it does not establish that two conditions are identical. The registry record lists no analysis entries and reports no p-value for the primary endpoint. Consequently, no significance test for the lens comparison can be described.
Why do multiple conditions matter?
The primary outcome includes three luminance-and-contrast conditions, and the record indicates that the outcome was not reduced to one comparison. When more than one comparison is examined, the interpretation may depend on whether the comparisons were prespecified and whether an approach to multiplicity was used. In general, multiplicity procedures address the increased chance of finding an apparently notable result when multiple hypotheses are tested. The registry record does not report a multiplicity strategy, a hierarchy among conditions, or the results for any individual condition.
What do the planning assumptions mean?
The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is expressed as the stated fraction of the observed effect. These are described as planning illustrations rather than the trial's own design justification. Sample-size illustrations concern the number of participants that might be needed under stated assumptions; they are not evidence about the power actually achieved in a completed trial. The registry record does not report the numerical illustrations or a trial-specific sample-size justification.
These general explanations do not establish which methods were applied in the analysis of this study. The specific model, handling of repeated measurements, assumptions, missing-data approach, and statistical testing plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint covers three testing conditions: high luminance and high contrast, high luminance and low contrast, and low luminance and high contrast with distance goggles. The registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It lists one outcome measure but no analysis entries. It does not report a hierarchy for the conditions, which comparisons were planned, or whether any adjustment for multiple comparisons was used.
In general, multiplicity matters when several hypotheses are tested because interpreting each test separately can increase the chance of a misleading positive finding across the set. A prespecified testing strategy can clarify which findings are confirmatory and how uncertainty should be interpreted. The registry record does not provide such a strategy, so no multiplicity-adjusted inference can be described.
The primary-outcome population is described as all subjects who successfully completed all visits. However, the record does not report how many subjects completed all visits, whether any measurements were missing, why measurements might have been missing, or how missing data were handled. It does not state whether the primary analysis included only complete cases or used another approach.
The record also does not report analysis-population definitions beyond the completed-visits description. Details about deviations from randomized sequence, exclusions, or treatment of participants who did not complete both periods are not reported in the registry record. These omissions limit assessment of how the analyzed population may relate to the randomized population.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Test (Etafilcon A) | 0 | 45 | 0.0% |
| Control (Hefilcon A) | 0 | 45 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test (Etafilcon A) | 0 of 45 |
| Control (Hefilcon A) | 0 of 45 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Test (Etafilcon A) | 0 of 45 |
| Control (Hefilcon A) | 0 of 45 |
The registry record lists serious adverse events, other adverse events, and deaths separately for groups titled Test (Etafilcon A) and Control (Hefilcon A). For each group, 45 subjects are listed as at risk for serious adverse events and 45 as at risk for other adverse events. The listed number affected is 0 for serious adverse events and 0 for other adverse events in each group. Deaths are listed as 0 in each group. No top serious-event terms are listed.
These entries describe what the registry reports for the listed groups and categories. A zero count means no affected subjects are recorded in that category; it does not establish that an event could not occur or that there is no uncertainty about safety. The record does not provide event narratives, follow-up details specific to safety, or additional information that would clarify how events were collected or adjudicated.
The study is a crossover, but the adverse-event entries are presented under the listed Test and Control group labels. The registry record does not explain the relationship between these safety denominators and randomized sequence, or give further details about exposure periods. The figures should therefore be read as registry counts rather than as a complete account of comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized comparison of two marketed reusable cosmetic contact lenses and describes how visual performance was assessed. It identifies a crossover structure, two lens-wear sequences, three measurement conditions, a mean logMAR endpoint, and the population intended for the primary outcome. It also records zero affected subjects for the listed serious and other adverse-event categories and zero deaths in both safety groups.
However, the record does not report numerical primary-outcome results or an analysis comparing the lenses. It therefore cannot establish the direction or size of a visual-performance difference, its precision, or whether a statistical test supported a difference. The absence of reported numerical results is not evidence that the measured outcomes were identical. Likewise, the safety counts should not be read as proof that no safety risk exists; they describe the counts recorded in the registry categories.
General interpretation of a crossover comparison depends on repeated measurements and their order. The registry record does not state how the statistical analysis handled those features. It also does not report the number who completed all visits, missing-data handling, or a strategy for interpreting the three conditions together.
The record's completed status means that the study is listed as completed; it does not fill in the absent outcome estimates. Nor do planning illustrations based on an observed effect establish observed power or provide a substitute for a reported analysis. The conclusions that can be drawn are therefore limited to the design, measurement description, and posted safety counts. Any stronger statement about comparative visual performance or the statistical evidence for a difference would require results and methods not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for using a crossover design to compare two lens conditions. In general, crossover studies can support within-participant comparisons, which may be useful when the outcome varies between individuals. At the same time, they require attention to the order and timing of measurements. The registry record identifies randomized sequences but does not report how those design features were addressed analytically.
The endpoint is also measured across more than one viewing condition. Visual performance was assessed under three combinations of luminance and contrast, rather than a single setting. This makes it important to know whether results were reported separately, whether a primary comparison was specified for each condition, and how multiplicity was handled. Those analysis details are not reported in the registry record.
For biostatistical interpretation, the distinction between a measurement plan and a reported result is central. The record gives a detailed account of how logMAR scores were obtained and what the scale means, but does not report the corresponding means, variability, comparisons, or uncertainty estimates. Consequently, the design can be described, but the primary statistical finding cannot be reconstructed from the registry entry.
The safety counts provide another useful lesson in reading registry data: counts of zero in listed categories are descriptive entries, not a complete estimate of all possible safety outcomes. Denominators, follow-up context, and event definitions all matter, and the record does not elaborate on them beyond the listed groups and categories.
The trial therefore illustrates why interpretation requires both a clear design and transparent results. The design and endpoint description help explain what was intended, while the missing comparative estimates and analysis details constrain what can be concluded statistically.
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 the primary endpoint is that numerical outcome results are not reported in the registry record. There are no condition-specific means or standard deviations, no lens contrasts, and no confidence intervals or p-values. The magnitude, direction, and precision of any observed difference therefore cannot be assessed.
The study measured visual performance under three conditions, but the registry record does not report condition-specific findings or a single comparison across them. It also does not describe a multiplicity plan. The record lists no analysis entries, leaving the statistical model, treatment of repeated measurements, and handling of period or sequence effects unspecified.
The primary-outcome population is defined by successful completion of all visits, but the number who met that definition is not reported. Missing measurements, withdrawals, exclusions, and their handling in the analysis are not described. Further participant characteristics and the allocation of subjects to the two sequences are also not reported.
Although the design is described as crossover, details about washout and carryover are not reported in the registry record. The record also describes the study as single-masked and brand-masked without identifying which parties were masked. These omissions limit assessment of the implementation and analysis of the design.
The adverse-event listings report zero affected subjects in the listed serious and other event categories and zero deaths, but provide limited contextual detail about event collection, exposure, or follow-up. Finally, planning illustrations are described as based on the observed effect, but the record does not report their numerical outputs or a trial-specific sample-size justification. Together, these limitations mean the registry record describes the study more fully than it reports its statistical findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses — NCT03755882.
- Registry record last updated 2020-02-05; status last verified 2020-01.
- Results first posted 2020-01-10.
- 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.
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18. Record Summary
The registry record describes a completed, randomized, single-masked, multi-site 2×2 crossover study of two marketed reusable cosmetic contact lenses. Enrollment was 46. Eligible subjects were female habitual reusable soft cosmetic lens wearers between the ages of 18 to 29 years, randomized to one of two lens sequences. Each lens type was worn for approximately 2 weeks over a 4-visit study.
The primary outcome was mean monocular visual performance in logMAR units under three luminance-and-contrast conditions, assessed with ETDRS charts at 4 meters. The stated primary-outcome population was subjects who successfully completed all visits. Numerical primary-outcome results and analysis entries are not reported in the registry record. The safety listings report zero serious adverse events, zero other adverse events, and zero deaths in each listed group.