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 Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (NCT01494818), a randomized na study. The primary outcome is Maximum Papillae.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01494818 |
| Phase | NA |
| Condition | Contact Lens Care |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 79 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Alcon Research |
| Results posted | Yes |
2. Clinical Question
Population
People using silicone hydrogel contact lenses on a daily-wear basis, with the primary outcome population described as enrolled and dispensed participants who completed the study per protocol. The registry lists 79 enrolled participants; the number completing the study per protocol is not reported in the registry record.
Intervention
A hydrogen peroxide-based contact lens care system, identified as CLEAR CARE/AOSEPT Plus, used according to the manufacturer’s instructions.
Comparator
A PHMB-containing multipurpose contact lens solution, identified as ReNu MultiPlus, also used according to the manufacturer’s instructions.
Primary question
How did the maximum eyelid papillae grade change or compare between the care-system groups from baseline to Month 3? The registry identifies this outcome and its assessment times, but does not report outcome values or a between-group estimate.
The study’s broader purpose was to assess and compare the effects of repeated use of the two care systems with silicone hydrogel lenses worn daily for three months. The stated focus included eyelid tissue and its associations with lens-surface wettability and contamination. The listed secondary outcomes concern tear-film break-up time, protective index, front-lens deposits, and lipid uptake per lens.
The registry describes a comparison of care systems, not a comparison of contact lens wear with no lens wear. It does not report enough outcome data to establish the direction or size of any difference in maximum papillae between groups. The clinical question is therefore identifiable, but the posted record does not provide the numerical results needed to answer it.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study, with 79 participants enrolled. It lists the study as completed and gives the condition as contact lens care. The phase is recorded as not applicable. The study evaluated two care systems alongside soft contact lenses: CLEAR CARE/AOSEPT Plus, a hydrogen peroxide-based system, and ReNu MultiPlus, a PHMB-containing solution. Both systems were used according to the manufacturer’s instructions.
The stated study period involved daily-wear silicone hydrogel contact lenses and repeated use of the care systems over three months. The primary outcome was assessed at baseline and Month 3. The registry does not report which people were masked, how random assignment was generated or concealed, or whether other features of trial conduct were masked. Those details should not be inferred from the single-masked label.
The primary-outcome population is described as all enrolled and dispensed participants who completed the study per protocol. The number in that population, the number assigned to each group, and the number who completed follow-up are not reported in the registry record. Although the registry lists 79 enrolled participants, enrollment alone does not establish how many participants contributed data to a particular endpoint.
The registry names four secondary outcomes: median non-invasive pre-lens tear-film break-up time, protective index, median front-lens deposits, and total lipid uptake per lens. It records eight outcome measures overall, but does not provide their numerical results in the record described. The planned allocation ratio, visit schedule beyond the primary outcome’s stated times, and detailed analysis procedures are not reported in the registry record.
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 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.
Overall Study
| Stage | CLEAR CARE/AOSEPT Plus | ReNu MultiPlus |
|---|---|---|
| STARTED | 39 | 39 |
| COMPLETED | 37 | 37 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | CLEAR CARE/AOSEPT Plus | ReNu MultiPlus |
|---|---|---|
| Relocation | 1 | 2 |
| Lost to Follow-up | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All enrolled and dispensed participants who completed the study as per protocol
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 reporting group includes all enrolled and dispensed participants who completed the study.
| Characteristic | Unit | CLEAR CARE/AOSEPT Plus | ReNu MultiPlus | Total |
|---|---|---|---|---|
| Participants analysed | 37 | 37 | 74 | |
| Age Continuous | years | 34.8 (SD 9.8) | 35.5 (SD 10.5) | 35.1 (SD 10.1) |
| Sex: Female, Male: Female | Participants | 21 | 25 | 46 |
| Sex: Female, Male: Male | Participants | 16 | 12 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Papillae, measured over Baseline, Month 3.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | Units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is maximum papillae, an assessment of bumps on the inner eyelid. Papillae were recorded separately for three zones of the upper lid and overall for the lower lid using a five-point forced-choice scale. The scale runs from 0, meaning none, to 4, meaning severe, with the intervening categories describing increasing grades of papillae. The maximum value represents the worse grade in any zone.
This maximum captures the most pronounced recorded grade rather than an average across eyelid zones. An ordinal scale is useful when observations fall into ordered categories, but the distance between adjacent categories should not automatically be interpreted as equal. A change from one category to another indicates a change in recorded grade; it does not by itself quantify a fixed amount of biological change.
The registry specifies the median and full range as the summary measures and gives baseline and Month 3 as assessment times. Both eyes were included in the model for analysis. The specific model and the results at either time are not reported in the registry record. Nor does the record provide a numerical summary of change or a between-group contrast. The endpoint definition explains what was measured, but without those results it does not show whether the recorded grades differed between care-system groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of CLEAR CARE/AOSEPT Plus and ReNu MultiPlus and names maximum papillae as the primary outcome. It does not report the observed median or full range for either group at baseline or Month 3, nor a numerical contrast between the groups. It also does not report a confidence interval, p-value, or other inferential result for this outcome. Consequently, the posted record does not establish the direction, magnitude, or precision of a between-group difference in maximum papillae.
The registry record lists eight outcome measures and four named secondary outcomes, but numerical results for those outcomes are not reported in the record described. The registry lists 0 analyses. This means a reader cannot use the posted information to assess whether the primary finding was statistically distinguishable from chance under a specified analysis, or whether secondary findings were consistent with it. Absence of a posted result is not evidence that the groups were identical; it is a limit on what can be concluded from the record.
As a general statistical point, an estimate describes the observed contrast, while a confidence interval describes the range of values reasonably compatible with the data and the analysis assumptions. A narrow interval would indicate greater precision than a wide interval, but neither the estimate nor its interval is reported. Statistical significance alone would not convey the size or practical relevance of an effect, and the record does not provide the data needed to evaluate either.
The outcome is ordinal and summarized using a median and full range. Those summaries can describe the distribution of grades, but they do not replace a prespecified comparison method. The registry does not report the statistical model, how baseline measurements entered the analysis, or how the inclusion of both eyes was handled. Therefore, no model-based interpretation can be reconstructed from the endpoint definition alone.
The enrollment figure should not be treated as the number analyzed for the primary endpoint. The specified population is participants who completed the study per protocol, but the size of that population is not reported in the registry record. Without group-specific analysis counts and outcome data, it is not possible to judge the extent or consequences of missing outcome observations.
In short, the record supplies a clear description of the study question and endpoint, but not the primary outcome result. Any conclusion about which care system had higher or lower papillae grades, or whether the groups differed, would go beyond what the registry record reports.
9. Statistical Methods Explained
The registry identifies the design as randomized, single-masked, and parallel-group. Randomization is intended, in general, to reduce systematic differences between groups at the start of a study. It does not guarantee balance in every characteristic, particularly in a study with limited enrollment, and it does not remove the need to describe how assignment was conducted. The method used to generate or conceal assignments is not reported in the registry record. The identity of the masked people is also not reported, so the masking label cannot establish whether participants, outcome assessors, or other study personnel were unaware of assignments.
The primary endpoint is an ordered categorical grade. In general, ordinal outcomes carry information about ranking: one category indicates a more severe grade than another, but category steps need not represent equal increments. Treating such a scale as though every step had the same quantitative meaning requires assumptions that should be justified by the analysis plan. The registry reports the median and full range, but does not report the inferential method used to compare groups or times.
A median is the middle value of an ordered set of observations. It is often useful when a distribution is skewed or when values are ordinal, because it is less influenced by extreme observations than a mean. A full range describes the lowest and highest observed values. Range summaries are sensitive to extreme observations and do not, by themselves, reveal how values are distributed between the endpoints. The registry’s choice of median and full range describes the intended summaries; the actual values are not reported in the registry record.
The endpoint uses the maximum grade across eyelid zones, so it represents the most severe recorded zone rather than a typical zone. This is a meaningful feature of the definition, but it also means the result depends on the set of zones assessed and the rule for selecting the maximum. The registry describes the scoring areas and maximum rule. Further details about assessor training, repeatability, and handling of uncertain grades are not reported in the registry record.
Both eyes were included in the model for analysis. As a general statistical consideration, measurements from two eyes of the same person may be correlated: they are not necessarily independent observations. Analyses of paired or clustered observations generally need to account for that dependence to avoid overstating the information in the data. The registry does not identify the model or explain how within-person correlation was handled, so the adequacy of that aspect cannot be evaluated from the record.
The study’s primary outcome has measurements at baseline and Month 3. In general, repeated measurements can be analyzed by comparing follow-up values, changes from baseline, or a model that uses measurements across time. These approaches answer related but not identical questions and can rely on different assumptions. The registry does not specify which approach was used, whether baseline values were adjusted for, or how the two assessment times were combined in an inferential analysis.
The record lists a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The registry does not report the trial’s own sample-size justification or the planning inputs beyond those stated assumptions. The listed assumptions cannot substitute for a reported design rationale.
More generally, a confidence interval expresses uncertainty around an estimate under the chosen model and assumptions. A p-value measures how compatible the data are with a specified null hypothesis under that analysis; it does not measure the probability that the null hypothesis is true or the clinical importance of a finding. Neither quantity can be interpreted for the primary outcome because the registry record does not report them. The record also does not report an analysis plan, interim analyses, multiplicity adjustments, or a prespecified hierarchy of outcomes.
The registry’s count of 0 analyses and the absence of a numerical primary result limit independent statistical interpretation. A reader cannot reproduce an estimate or test from the endpoint description alone. Any recalculation would require posted group summaries and analysis details; those are not reported in the registry record. Therefore, the design labels and endpoint definitions explain the intended comparison, but do not provide a basis for reconstructing its statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures, including the primary outcome and four named secondary outcomes. The other outcome measures are not identified in the record described. When a study assesses multiple outcomes, time points, or comparisons, the chance of at least one apparently unusual result can increase if each is tested separately. General approaches include prespecifying a primary comparison, controlling the family-wise error rate, or treating secondary analyses as exploratory. The registry does not report a multiplicity strategy, an outcome hierarchy, or an adjustment method.
The primary outcome is specified at baseline and Month 3, but the registry does not state which time point or contrast was designated as the principal inferential comparison. Its description notes that the primary outcome has several categories or time points and was not reduced to one comparison. The record lists 0 analyses and does not provide a primary-outcome estimate or test. No conclusion about multiplicity-adjusted or unadjusted statistical evidence can therefore be drawn from the record.
For missing data, the primary-outcome population is described as enrolled and dispensed participants who completed the study per protocol. The number meeting that definition, the number with endpoint observations at each time, and reasons for missing observations are not reported in the registry record. The record does not describe imputation, sensitivity analyses, or another method for handling missing data. It is therefore not possible to assess whether the reported analysis population differed from the enrolled population or whether missing observations could affect an estimate.
The registry does not report whether the primary analysis followed randomized assignment regardless of adherence, or whether it used another population definition beyond the stated per-protocol completion description. This limits interpretation of the estimand and the role of post-randomization exclusions. These are reporting gaps; they do not establish that an analysis or adjustment was not conducted outside the registry record.
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 |
|---|---|---|---|
| CLEAR CARE/AOSEPT Plus | 2 | 39 | 5.1% |
| ReNu MultiPlus | 0 | 39 | 0.0% |
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 |
|---|---|
| CLEAR CARE/AOSEPT Plus | 3 of 39 |
| ReNu MultiPlus | 0 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | CLEAR CARE/AOSEPT Plus | ReNu MultiPlus |
|---|---|---|---|
| Hysterectomy | Surgical and medical procedures | 1 of 39 | 0 of 39 |
| Hospitalization | Skin and subcutaneous tissue disorders | 1 of 39 | 0 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CLEAR CARE/AOSEPT Plus | ReNu MultiPlus |
|---|---|---|---|
| Toxic reaction to solution | Eye disorders | 3 of 39 | 0 of 39 |
Serious events with the highest arm-level rate: hysterectomy (2.6%), hospitalization (2.6%).
The registry lists serious adverse events for the two groups. For CLEAR CARE/AOSEPT Plus, it records 39 at risk and 2 affected; for ReNu MultiPlus, it records 39 at risk and 0 affected. For other adverse events, it records 39 at risk and 3 affected in the CLEAR CARE/AOSEPT Plus group, and 39 at risk and 0 affected in the ReNu MultiPlus group. These are registry counts, not a comparative statistical analysis. The record does not report confidence intervals or a test of between-group differences for these figures.
The top serious-event terms are listed as Hysterectomy at 2.6% and Hospitalization at 2.6%. The record does not provide enough detail to determine from these labels whether the terms refer to distinct events, how they relate to the affected counts, or whether one participant could contribute more than one event. The deaths fields are null, so deaths are not reported in the registry record.
These figures should be read as safety information recorded during the study, not as proof that a care system caused or prevented an event. The record does not report event timing, relatedness assessments, severity details beyond the serious-event classification, or a fuller narrative. Small counts and absent context limit comparisons. The enrollment figure should not be substituted for the adverse-event risk denominators, which the registry lists separately for each group.
12. What the Result Does, and Does Not, Mean
The registry record makes the study’s intended comparison understandable: two contact lens care systems were evaluated in daily-wear silicone hydrogel lens users, with maximum eyelid papillae as the primary outcome and assessments at baseline and Month 3. It also defines how papillae were graded and identifies secondary ocular-surface measures. Those details explain what investigators set out to measure.
They do not establish what the comparison found. Numerical primary-outcome results, group-specific endpoint summaries, a between-group estimate, and inferential statistics are not reported in the registry record. The four named secondary outcomes also lack numerical results in the record described. It is therefore not possible to say from the posted information that one group had higher or lower grades, that there was a statistically supported difference, or that there was no difference.
Even if a difference were reported, its interpretation would depend on its magnitude, uncertainty, analysis population, and the appropriateness of the statistical model. For an ordinal endpoint, a difference in grade categories is not automatically a fixed-size change on a continuous scale. For measurements from both eyes, accounting for correlation within a participant is a general analytical consideration. The registry does not report enough methods or results to evaluate these matters.
The adverse-event counts offer limited descriptive safety information but do not demonstrate a causal relationship between a care system and an event. They are not a substitute for the missing primary efficacy or ocular-tissue results, and they do not support a broader safety comparison without further context.
The study record can thus be used to identify the design, intervention groups, endpoint definition, and some reported safety counts. It cannot support a conclusion about the primary outcome’s direction, size, precision, or statistical significance. Those limits concern the information recorded in the registry and should not be confused with a claim about results that may be reported elsewhere.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the registry gives a relatively specific endpoint definition while leaving the outcome result unavailable. A precisely described question is important, but a question alone cannot show what was observed. Readers need group-specific summaries and a defined comparison to assess the direction and size of an effect, along with uncertainty measures to judge precision.
The maximum papillae grade is ordinal and based on the worst grade among specified eyelid zones. That construction has implications for interpretation: it focuses on the most severe recorded site, and category values indicate ordered severity rather than necessarily equal quantitative steps. Reporting the chosen summary and analysis method is therefore particularly important. The registry identifies the median and full range, but does not report the statistical comparison or its result.
Including both eyes in the model also raises a general issue of correlated observations. Two measurements from the same participant may share characteristics and should not automatically be treated as independent. The registry states that both eyes were included but does not describe the model, making it impossible to assess how this dependence was handled.
The record also illustrates why enrollment, analysis population, and outcome availability are different concepts. It lists 79 enrolled participants but defines the primary population by per-protocol completion, without reporting the number meeting that definition. Without analysis counts and missing-data information, the relation between enrollment and the endpoint result cannot be assessed.
Finally, the record lists multiple outcome measures but does not report a multiplicity plan or analysis results. Prespecification and transparent reporting help readers distinguish a principal test from exploratory comparisons. Here, the design and measurement are described, but the statistical evidence needed to interpret the primary question is not reported in the registry record.
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 interpretation is the absence of numerical primary-outcome results. The registry describes the maximum papillae measure, its scale, summaries, and assessment times, but does not give the observed group values or a between-group estimate. It also does not report a confidence interval or p-value. As a result, the primary comparison cannot be quantified or independently evaluated.
The primary analysis population is described as participants who completed the study per protocol, but the size of that population and group-specific endpoint counts are not reported in the registry record. Completion and missingness details, reasons for missing observations, and the method used to handle missing data are also not reported. These gaps limit assessment of selection and attrition.
Although the registry identifies the study as randomized and single-masked, it does not report the sequence-generation or allocation-concealment methods, who was masked, or the statistical model. Both eyes were included in the model, but the approach to within-participant correlation is not described. The record also does not state how baseline measurements entered the analysis.
The registry lists eight outcome measures but provides only four named secondary outcomes in the record described. It does not report an outcome hierarchy, multiplicity approach, or interim-analysis information. The trial’s own sample-size justification and full statistical plan are not reported. These omissions prevent a complete assessment of the design and analysis choices.
The safety information is limited to the listed counts and top serious-event terms; timing, relatedness, and detailed event descriptions are not reported. These limitations apply to interpretation of the registry record and do not establish what information may appear in other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues — NCT01494818.
- Registry record last updated 2013-09-27; status last verified 2013-07.
- Results first posted 2013-09-27.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT01494818, a completed randomized, single-masked, parallel-group study of two contact lens care systems used with daily-wear silicone hydrogel lenses over three months. It lists 79 enrolled participants and identifies maximum eyelid papillae as the primary outcome, assessed at baseline and Month 3. The endpoint uses a five-point forced-choice grade, with the maximum representing the worse grade in any zone, and includes both eyes in the model.
The record names four secondary outcomes concerning tear-film break-up time, protective index, lens deposits, and lipid uptake. It lists adverse-event counts for each group, but does not report primary-outcome results, a statistical comparison, confidence intervals, or p-values. The number completing the study per protocol and detailed analysis methods are not reported in the registry record. The study question and outcome definitions are available, but the posted information does not establish the comparative primary-outcome result.