An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (NCT01594294), a randomized na study. The primary outcome is Maximum Papillae.

2. Clinical Question

The study asked whether eyelid papillae differed over a 3-month period of daily contact lens wear when participants used AOSEPT Plus or ReNu MultiPlus care systems with the study’s contact lenses. The registry record also describes COMPLETE MPS Easy Rub as part of a screening phase, rather than as one of the two investigational care-system arms.

The endpoint reflects the highest papillae grade found among specified eyelid zones, rather than a separate result for every zone. It was assessed without contact lenses being worn. The registry record says both eyes were included in the model for analysis, but it does not describe the model or how measurements from the two eyes were handled.

The clinical question is therefore identifiable, but the posted information does not establish the size or direction of any difference between care systems. It also does not provide enough detail to characterize the enrolled participants beyond the recorded condition of myopia and the stated analysis-population definition.

3. Trial Design

This was a randomized, single-masked, parallel-group study recorded as completed. The registry lists an enrollment of 100 and identifies myopia as the condition. The study start is recorded as 2012-04 and primary completion as 2013-06. The study phase is listed as NA. The identity of the masked party and the allocation procedure beyond randomization are not reported in the registry record.

The brief description concerns repeated use of two care systems with ACUVUE 2 and AIR OPTIX AQUA contact lenses worn on a daily-wear basis for a 3-month period. The arm descriptions specify AOSEPT Plus or ReNu MultiPlus with etafilcon A or lotrafilcon B lenses during the investigational phase. COMPLETE MPS Easy Rub appears in the intervention list and is described as being used during screening: with etafilcon A for 14 days or lotrafilcon B for 30 days. These screening details should not be confused with the 3-month investigational-phase descriptions.

The registry does not state how participants were distributed among arms, how lens types were assigned, whether assignments were stratified, or how adherence was monitored. It does not report a participant flow, the number who completed each arm, or the number assessed at each time point. Although the overall enrollment is recorded, the analyzed sample size is not given.

The primary endpoint was assessed at Baseline (Day 0) and Month 3. Contact lenses were not worn for this assessment. The registry describes a population of protocol completers minus missing responses, but does not explain whether other analysis populations were used. Detailed protocol procedures, sample-size justification, and the prespecified statistical plan are not reported in the registry record. The design features establish the broad comparison and timing, but do not by themselves show how the primary comparison was estimated.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).

Overall Study

Analysis population for the primary outcome, as defined in the registry: This analysis population includes all participants who completed the study as per the protocol, minus missing responses.

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: This analysis population includes all participants who completed the study as per the protocol.

6. Primary Endpoint

The registry lists the primary outcome as Maximum Papillae, measured over Baseline (Day 0), Month 3.

The primary endpoint, Maximum Papillae, records the highest eyelid papillae grade observed across the specified zones. Papillae are described as bumps on the inner eyelid. The upper lid was recorded separately for three zones, while the lower lid was recorded overall. A 5-point forced-choice scale ran from 0, None, through 1, Slight, 2, Mild, and 3, Moderate, to 4, Severe. The endpoint takes the maximum grade across zones, so it represents the worst recorded grade rather than an average across the eyelid.

The endpoint was specified at Baseline (Day 0) and Month 3. The registry says contact lenses were not worn during this assessment and both eyes were included in the analysis model. The method used to combine or otherwise account for the two eyes is not reported in the registry record.

As a general statistical point, an ordinal grade preserves an ordering of severity categories, but the gaps between adjacent categories are not necessarily equal. A median can describe the middle of an ordered distribution without requiring that category spacing be treated as equal. The maximum across zones can be useful when the question concerns the most pronounced finding, but it does not describe how widespread the finding was or how grades differed among zones.

The endpoint’s definition and measurement schedule are recorded, but the arm-level medians, ranges, changes over time, and comparative estimates are not reported in the registry record. Therefore the measure can be described, but its observed pattern cannot be interpreted from the registry results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the endpoint as a median with full-range dispersion, measured at Baseline (Day 0) and Month 3. It says both eyes were included in the analysis model. The detailed statistical method, including the model form, treatment of repeated measurements, and handling of the two eyes, is not reported in the registry record. No inferential analysis is listed.

What does a median describe?

As a general statistical explanation, the median is the central value when observations are ordered. It is often useful for ordered outcomes because it identifies a typical position in the distribution without assuming that the distance between categories is constant. Here the categories have an explicit order from None to Severe, but their labels do not establish equal spacing. A median alone does not show the number of observations in each category or reveal whether values cluster near the center or at the extremes.

The registry’s full-range description refers to the lowest and highest recorded values. In general, a range gives a compact view of the spread’s endpoints, but it does not describe how observations are distributed between them. Neither the median nor the range can be interpreted for the study arms because their numerical results are not reported in the registry record.

Why does the maximum across zones matter?

The endpoint takes the worst grade across three upper-lid zones and the lower lid overall. In general, using a maximum focuses on the most pronounced recorded location. It can make the summary sensitive to a high value in any included zone, while hiding whether the same grade was present in multiple zones. It is not equivalent to an average or a total score. The registry does not report separate zone-level results, so those patterns cannot be examined.

How should two eyes and repeated assessments be considered?

The registry says both eyes were included in the model and identifies two assessment times. As a general statistical matter, measurements from the same participant’s eyes may be related, and measurements from the same participant across time may also be related. An analysis that treats related observations as independent can misstate uncertainty. Appropriate modeling can account for such dependence, but the particular model and its assumptions are not reported in the registry record. The statement that both eyes were included does not reveal whether eye-level observations were modeled jointly, summarized within a participant, or handled another way.

The time points also invite a distinction between comparing arms at Month 3 and comparing changes from baseline. These answer related but different questions. A change analysis may account for baseline values, while a follow-up-only comparison focuses on the endpoint values at the later assessment. The registry names both times but does not identify which contrast was used or report an estimate for either approach.

What can uncertainty and significance tell a reader?

As a general explanation, a confidence interval describes statistical uncertainty around an estimate under a particular model and sampling framework. A narrow interval indicates greater precision than a wide interval, while the interval’s location helps show which effect values are compatible with the data. A p-value, when reported, summarizes how unusual data at least as inconsistent with a specified null model would be, assuming that model and its assumptions. Neither measure alone establishes clinical importance or causation. The registry record reports no confidence interval, p-value, or primary-outcome estimate, so none can be interpreted for this comparison.

What does the planning illustration represent?

The record describes sample-size planning illustrations based on a stated fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For non-time-to-event outcomes, the stated convention is participants per arm for the specified power; time-to-event planning uses a total number of events. These are planning assumptions, not observed trial results and not observed power. The registry does not report the trial’s own sample-size justification or the numeric planning-illustration values in the information recorded for this analysis. The observed primary effect itself is not reported in the registry results.

Over-dispersion is a general concern when observed variability exceeds what a chosen model assumes; it can make standard errors too small if the model does not account for that extra variability. The registry does not report a model or diagnostics that would allow assessment of over-dispersion, and the ordered endpoint’s distribution is not posted. No specific statistical method should therefore be attributed to the study beyond the endpoint summary and analysis details that the registry states.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 5 outcome measures, while the analysis count is 0. The primary outcome is assessed at Baseline (Day 0) and Month 3, and the record notes that the primary outcome has several categories or time points and was not reduced to one comparison. This means the posted record does not supply a single primary comparison for interpretation.

As a general statistical point, evaluating multiple outcomes, time points, or contrasts can increase the chance of finding an apparently notable result when many tests are considered. A prespecified testing strategy or multiplicity adjustment can address that issue, but the statistical plan and any multiplicity procedure are not reported in the registry record. No adjustment should be assumed.

The primary-outcome population is described as all participants who completed the study as per protocol, minus missing responses. This is not the same description as an analysis of every randomized participant. The number of participants excluded for missing responses, the amount and pattern of missing data, and the number analyzed at each assessment are not reported in the registry record. The handling of missing values, including any imputation or sensitivity analysis, is also not reported.

As a general explanation, missingness can affect interpretation when the likelihood of a missing observation is related to the outcome or to participant characteristics. Excluding missing responses may be reasonable under some conditions, but without counts and assumptions the effect of that exclusion cannot be judged. The record does not describe whether the analysis population was prespecified or whether any additional populations were examined. These omissions limit the ability to assess both multiplicity and the robustness of the primary endpoint analysis.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: fall causing crack on the skull and internal bleeding (2.6%), fibroids (2.6%), hernia (2.6%), dehydration and possible chest infection (2.6%).

The registry lists 39 participants at risk in each of the two care-system groups. The serious adverse event figures list 2 affected in the AOSEPT Plus group and 2 in the ReNu MultiPlus group. The other adverse event figures list 3 affected in the AOSEPT Plus group and 0 in the ReNu MultiPlus group. These are posted counts, not estimates of a causal effect.

The record lists the following serious-event terms among its top terms: Fall causing crack on the skull and internal bleeding, 2.6%; Fibroids, 2.6%; Hernia, 2.6%; and Dehydration and possible chest infection, 2.6%. The record does not assign those terms to a particular care-system group in the information, so an arm-specific attribution should not be made.

Deaths are not reported in the registry record. The safety information does not provide event timing, duration of exposure, definitions used for event categories, or an analysis comparing groups. As a general statistical point, adverse-event counts are descriptive unless accompanied by a design and analysis that address exposure, chance variation, and other potential explanations. The counts alone do not establish that a care system caused or prevented an event, and they do not show whether a difference is statistically precise.

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

The registry record supports a description of the trial’s question, design, endpoint definition, analysis-population wording, and some safety counts. It does not report the arm-level values for Maximum Papillae or a statistical comparison between AOSEPT Plus and ReNu MultiPlus. Thus, the posted results do not establish the direction, magnitude, or precision of the primary endpoint contrast.

This absence should not be read as evidence of no difference. A finding of no statistically significant difference would require reported analysis results, and a claim of equivalence or non-inferiority would require an appropriate framework and prespecified criteria. Neither is reported in the registry record. The endpoint description alone cannot show that the care systems produced similar or different eyelid findings.

The design details also do not answer every question about applicability. The registry identifies myopia, contact lens care systems, lens types, and daily wear, but additional participant characteristics and the distribution of lens types across groups are not reported. The participant-level analysis sample and missing-response counts are not given. These details matter when judging how broadly any result might apply, but the absent primary results prevent that assessment in the first place.

The adverse-event counts provide limited descriptive information for the two groups. They should not be treated as proof of safety or harm, and the serious-event terms are not tied to arms in the record. A reader cannot infer causal attribution from these figures alone.

In general, trial interpretation depends on both an effect estimate and its uncertainty, alongside design, missing-data handling, and outcome definitions. In this record, the endpoint is clearly described, but the numerical primary findings and inferential analyses are not reported. Any conclusion about comparative effects would therefore go beyond the registry information.

13. Why This Trial Matters Statistically

This trial is statistically notable for the gap between a defined primary endpoint and the absence of posted primary analysis results. The registry specifies the construct, scoring scale, assessment times, and analysis-population wording. Those details help identify what investigators intended to measure, but they do not provide the evidence needed to estimate a comparison.

The endpoint also illustrates why outcome scale matters. Maximum Papillae is an ordered grade, and the analysis summary is a median with full range. In general, ordinal categories should not automatically be treated as equally spaced numerical measurements. Reporting category distributions alongside a median can make interpretation more complete, but the registry record does not provide the arm-level values or category breakdowns.

Both eyes were included in the stated model, and the endpoint was assessed at baseline and Month 3. These features raise statistical questions about correlated observations and repeated measures. The record does not give the model specification, so readers cannot determine how those dependencies were addressed. This is an important distinction between knowing that measurements were collected and knowing how the uncertainty of a comparison was estimated.

The population is described as protocol completers minus missing responses. Without participant counts, missingness details, or sensitivity analyses, the effect of that analysis choice cannot be assessed. Likewise, multiple outcome measures and time points make a prespecified testing strategy relevant, but no multiplicity plan is reported.

Finally, the adverse-event counts are descriptive and lack a posted comparative analysis. Together, these features show why transparent reporting needs more than endpoint definitions and enrollment totals: readers also need analyzed sample sizes, effect estimates, uncertainty, and enough methodological detail to understand how those estimates were obtained.

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 central limitation is that arm-level primary endpoint values and comparative analyses are not reported in the registry record. The study’s endpoint can be described, but its observed distribution and any between-group effect cannot be evaluated. The record lists zero analyses.

The registry does not report the detailed statistical model, the method used to account for both eyes, or whether the primary comparison concerned Month 3 values or change from baseline. It also does not report confidence intervals, p-values, or a multiplicity procedure. The primary outcome spans multiple categories or time points and is not reduced to one comparison in the posted information.

The analysis population is defined as protocol completers minus missing responses, but the number excluded, missingness pattern, analyzed sample at each time point, and missing-data methods are not reported. The enrollment is recorded as 100, but arm-level enrollment and completion counts are absent. Allocation details beyond randomization, the identity of the masked party, and the distribution of lens types are also not reported in the registry record.

The safety information gives counts but not event timing, exposure-adjusted analyses, or arm-specific assignments for the listed serious-event terms. Deaths are not reported in the registry record. The record also does not include enough information to assess how adverse events were classified or whether the reported counts represent unique participants or event episodes.

These limitations concern reporting in the registry record; they do not establish what may have been planned or analyzed outside it. Protocol details, sample-size justification, interim analyses, and the statistical plan are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues — NCT01594294.
• Registry record last updated 2014-07-25; status last verified 2014-06.
• Results first posted 2014-07-25.
• 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 a completed randomized, single-masked, parallel-group study with enrollment of 100 and myopia as the recorded condition. The study compared AOSEPT Plus and ReNu MultiPlus care systems with specified contact lenses over a 3-month investigational phase; COMPLETE MPS Easy Rub is described for screening. Primary completion is recorded as 2013-06.

The primary endpoint was Maximum Papillae, an ordered 0-to-4 grade summarized by median and full range at Baseline (Day 0) and Month 3. Both eyes were included in the analysis model, and contact lenses were not worn for the assessment. The analysis population is described as protocol completers minus missing responses.

Arm-level primary outcome results and statistical analyses are not reported in the registry record. Safety counts list serious adverse events affecting 2 of 39 at risk in each group and other adverse events affecting 3 of 39 in the AOSEPT Plus group and 0 of 39 in the ReNu MultiPlus group. Deaths are not reported in the registry record.