Investigational Multi-purpose Contact Lens Care Solution.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Investigational Multi-purpose Contact Lens Care Solution. (NCT01055613), a randomized na study. The primary outcome is Slit Lamp Findings.

2. Clinical Question

The clinical question is therefore about whether the recorded eye findings differed between the two care-solution groups during the study, not about a single reported numerical effect. The registry describes eye examinations using a bio-microscope and a five-grade scale from none to severe. It states that findings at Grade 3 or higher were counted for each lens at each assessment, with a three-month timeframe. Because findings were collected across assessments and the outcome was not reduced to one comparison, the registry record does not establish a single effect estimate for this question.

The study was randomized, triple-masked, and parallel. These design features describe how the trial was organized, but they do not substitute for the missing outcome summaries or analysis. Without reported group results and an analysis, the clinical question remains unanswered in the registry record.

3. Trial Design

The registry identifies NCT01055613 as a completed, randomized, triple-masked, parallel study of contact lens care solutions. It compares Vistakon Investigational Multi-Purpose Solution I with ReNu MultiPlus Multi-Purpose Solution. Both are described as multipurpose contact lens care solutions, and the registry summary characterizes the investigational solution as being compared with a currently marketed solution.

Enrollment is recorded as 312. The registry lists the phase as NA. The study start is recorded as 2009-11 and primary completion as 2010-05. The sponsor is Johnson & Johnson Vision Care, Inc. The registry status is COMPLETED.

Randomized allocation means participants were assigned through a random process, as described by the registry design label. Triple masking indicates that the record classifies the trial as masked at three levels, but the registry entries do not identify which people or roles were masked. The parallel model indicates that the study compared groups followed within the same trial rather than describing a crossover design. These design labels do not reveal allocation procedures, the exact masking arrangements, adherence, or the timing of every assessment; those details are not reported in the registry record.

The primary outcome description concerns slit-lamp findings in eyes. The record defines the analysis population as all subjects dispensed a solution during the study. That definition is distinct from the enrollment figure: the registry does not explain the relationship between enrollment and the population contributing to each outcome, nor does it provide outcome-specific participant or eye counts.

The record lists two outcome measures and no statistical analyses. It does not provide numerical primary-outcome results, an estimated contrast between groups, or an uncertainty interval. Consequently, the design can be described, but the effect of the investigational solution relative to the comparator cannot be estimated from the registered results.

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: A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analysis population consists of all subjects that were dispensed a solution during the course of the study.

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 dispensed a study lens.

6. Primary Endpoint

The registry lists the primary outcome as Slit Lamp Findings, measured over 3 months.

The primary endpoint, titled Slit Lamp Findings, concerns findings observed when each subject’s eye was examined using a bio-microscope. The registry describes a five-point grading scale: Grade 0 means none, Grade 1 trace, Grade 2 mild, Grade 3 moderate, and Grade 4 severe. The reported endpoint was the number of eyes with Grade 3 or higher for each lens at each assessment. The timeframe is three months.

This kind of endpoint records observed eye findings using a defined grading system. Counting findings at or above a specified grade focuses attention on findings classified as moderate or severe, rather than treating every grade as equivalent. In general, a prespecified threshold can make an outcome easier to interpret as a count, while retaining the underlying clinical grading scheme.

The registry does not report the counts at the assessments, the number of eyes evaluated at each assessment, or a comparison between the solution groups. It also does not report the distribution across all five grades. As a result, the endpoint definition is available, but the observed outcome and its precision are not. The registry’s description that findings were reported at each assessment means the endpoint involves multiple assessment-specific values rather than one result that can be reconstructed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study as randomized, triple-masked, and parallel, and it describes a count-based primary outcome collected at assessments during a three-month timeframe. The record does not give the statistical analysis methods. The explanations below are general: they describe concepts relevant to this kind of outcome, not methods confirmed as having been used in the trial.

What does a count outcome represent?

A count records how many eligible units meet a defined condition. Here, the condition is a slit-lamp grade of Grade 3 or higher, and the counted units are eyes. A count is not the same as a proportion. Interpreting a count requires knowing the number of eyes assessed and the relevant group structure, because counts can be affected by how many units are observed. The registry does not report assessment-specific counts or the number of eyes contributing to them.

Counts can also arise from observations that are related rather than independent. For example, when outcomes are recorded for eyes belonging to the same subject, the observations may be correlated. In general, an analysis that treats correlated observations as independent can understate uncertainty. Appropriate methods may account for clustering or repeated observations, but the registry record does not state whether such methods were used. This is a methodological consideration, not a claim about the trial’s analysis.

Why can over-dispersion matter?

In general, a basic count model often makes assumptions about how much the counts vary around their expected values. Over-dispersion means the observed variability is greater than the model assumes. If it is ignored, standard errors and confidence intervals may be too small, making an estimate appear more precise than it is. Other sources of variability can include differences between subjects, repeated assessments, and unequal opportunities to observe an outcome. The registry provides no dispersion measure or model specification, so it is not possible to assess whether over-dispersion was considered for this trial.

What would a group comparison need to report?

A useful comparison would identify the outcome summarized for each group and the contrast used to answer the trial question. Depending on the analysis, a contrast could be expressed on a count scale or another scale selected for the analysis. The report would also need an uncertainty measure, such as a confidence interval, and enough information to understand how repeated assessments and the eye-level observations were handled. No such estimate or interval is reported in the registry record.

A confidence interval is a general statistical way to express the uncertainty around an estimated effect under the assumptions of the analysis. It does not remove uncertainty, and its width depends on the data and the model. Without an estimate, interval, and method, the precision of this trial’s primary comparison cannot be described. A p-value alone, even if one were reported, would not convey the size or precision of an effect; no primary-outcome p-value is reported in the registry record.

How does the assessment schedule affect interpretation?

The endpoint description refers to counts at each assessment, rather than giving one combined value. Repeated measurements can provide information about how observations vary over time, but they also raise analysis questions. A method could compare groups at each assessment, model the assessment pattern jointly, or define a particular assessment as the main comparison. These approaches answer different questions and may handle within-subject correlation differently. The registry does not report the assessment schedule beyond the three-month timeframe, nor does it specify a method for combining or comparing the assessment-specific values.

When several time points or categories are examined, multiplicity is a general concern. Conducting multiple tests can increase the chance of finding at least one apparently notable result by chance if the tests are interpreted without accounting for the number and structure of comparisons. A prespecified analysis strategy can define which comparisons are primary and how any additional analyses are interpreted. The registry record does not report a multiplicity strategy or a single reduced comparison for this outcome.

What can the design labels tell us?

Randomization is generally used to create groups that are comparable on average at the point of assignment, subject to the allocation process and trial conduct. Masking is generally intended to reduce the influence of knowledge of treatment assignment on behavior, assessment, or interpretation. A parallel design compares separate groups. These are design principles; their presence in the registry does not reveal the specific allocation method, masking roles, adherence, or whether all randomized participants contributed data to each analysis.

For this endpoint, the analysis population is described as all subjects dispensed a solution during the study. The record does not state how missing observations were handled, whether exclusions occurred, or whether the analysis followed a different population definition. These details matter because an analysis restricted to observed outcomes can differ from one that handles missing data under explicit assumptions. The relevant analysis population and missing-data method are not reported in the registry record.

In short, count-data methods, correlation, over-dispersion, repeated assessments, and multiplicity are relevant general considerations for this endpoint. The registry does not document which methods were selected or provide the numerical outcome data needed to evaluate an analysis. The trial-specific statistical result and its precision therefore remain unreported.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is described as counts of eyes with Grade 3 or higher slit-lamp findings for each lens at each assessment. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. This makes the absence of a stated analysis strategy important: the record does not identify which assessment or contrast should be treated as the primary statistical test, or how multiple comparisons were handled.

In general, multiplicity arises when several hypotheses or outcome comparisons are considered. Without a prespecified approach, interpreting one result among many can make chance findings more difficult to distinguish from consistent evidence. The registry record does not report whether comparisons were adjusted, prioritized, or treated as descriptive. It also does not report a primary-outcome p-value or estimate that would allow readers to assess any comparison.

Missing-data handling is not reported in the registry record. The endpoint description gives an analysis population of all subjects dispensed a solution, but does not state how subjects or eyes without an assessment were treated, whether any data were excluded, or what assumptions were used. The registry also does not provide the number of eyes evaluated at each assessment.

The record lists two outcome measures and no statistical analyses. It does not specify whether the outcome analyses used the same population, how repeated observations were handled, or whether the defined population was applied in practice. These gaps prevent assessment of the multiplicity, missing-data, and analysis-population decisions for the primary outcome.

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

Serious events with the highest arm-level rate: microbial keratitis (0.5%).

The registry reports serious adverse-event figures separately for the two groups. For the Experimental Multi-purpose Solution group, 200 were at risk and 1 was reported as having a serious adverse event. For the ReNu MultiPlus Multi-Purpose Solution group, 100 were at risk and 0 were reported as having a serious adverse event. The record lists Microbial Keratitis at 0.5% among the top serious terms.

For other adverse events, the registry reports 0 affected among 200 at risk in the experimental group and 0 affected among 100 at risk in the comparator group. Deaths are not reported in the registry record; the death fields are not presented as zero counts.

These entries are descriptive safety counts. They do not by themselves establish whether an event was caused by a solution, whether groups differed in risk, or how precisely a comparative safety effect could be estimated. The registry record does not provide a causal assessment, an uncertainty interval, or further detail connecting the listed serious term to the group-level count. The serious-event and other-event categories should be read as separate reported fields rather than combined into a new total.

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

The registry establishes that a randomized, triple-masked, parallel study compared an investigational multipurpose contact lens care solution with ReNu MultiPlus. It defines the primary outcome as the number of eyes with Grade 3 or higher slit-lamp findings at each assessment, over a three-month timeframe. It also gives limited group-level adverse-event counts.

Those details do not establish the primary outcome result. No assessment-specific eye counts, group contrast, confidence interval, or primary-outcome test is reported in the registry record. The magnitude and direction of any difference in slit-lamp findings are therefore unknown from this record. The absence of a reported analysis is not evidence that the groups had the same outcome, just as the design description is not evidence of a particular outcome.

The safety entries also have a limited interpretation. They report one serious adverse event in the experimental group and none in the comparator group, with the respective at-risk counts recorded by the registry. A serious event entry does not show that the study solution caused the event. The listed Microbial Keratitis term and its reported 0.5% do not, by themselves, establish causation or a comparative risk. The record gives no deaths count.

In general, a complete interpretation of a clinical comparison uses the observed outcome values, a clearly described analysis, and measures of uncertainty, considered alongside the trial design and limitations. Here, the endpoint definition and design are documented, but the primary results and analysis are not. The record can therefore support a description of what the trial was designed to examine, but not a conclusion about the size, precision, or direction of the primary outcome effect.

Nor does the registry information support a clinical recommendation. It does not present enough outcome evidence to determine comparative performance. Any further interpretation would require results and methods not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because its primary outcome is not a single simple value in the registry record. It is a count of eyes meeting a grading threshold at each assessment. That structure raises general analysis questions about the unit being counted, repeated observations, and how an overall comparison should be defined. Those questions are relevant even before considering which statistical model might be appropriate.

The study design labels—randomized, triple-masked, and parallel—give useful context for how the comparison was organized. But statistical interpretation depends on more than design labels. Readers also need the observed group outcomes and the method used to estimate a comparison. The registry does not report those primary-outcome results or analyses, so the design cannot be translated into an estimate of effect or precision.

The endpoint’s focus on Grade 3 or higher findings illustrates how a graded clinical observation can be converted into a threshold-based count. That can make a specific part of the grading scale the focus of analysis, but it also means the reported count would not describe the full distribution of grades. The registry does not provide either the threshold counts or the distribution across grades, limiting interpretation of the endpoint.

The safety record also illustrates why descriptive event counts need careful framing. Counts and at-risk denominators convey what the registry recorded, but without causal assessment and uncertainty measures they do not establish a comparative safety effect. This is especially important when a record provides sparse event information alongside no primary-outcome analysis.

The statistical importance of the record is thus partly about the distinction between a well-defined question and an answer to that question. The registry identifies the comparison and the endpoint definition, but does not report the outcome analysis needed to quantify the comparison. That distinction prevents a design description from being mistaken for evidence about the result.

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 is that numerical results for the primary outcome are not reported in the registry record. The endpoint is defined, but no assessment-specific counts, group comparison, confidence interval, or test result is available. Consequently, neither the direction nor the precision of a primary-outcome difference can be evaluated.

The endpoint involves multiple assessments, but the registry does not report the full assessment schedule or identify a single comparison. It does not describe how repeated observations or eye-level data were handled, whether findings from two eyes of a subject were treated as related, or whether the analysis accounted for clustering. These are unresolved methodological details, not evidence that any particular analysis was used.

The registry defines the analysis population as all subjects dispensed a solution, but does not provide outcome-specific participant or eye counts, explain any exclusions, or describe missing-data handling. The relationship between the enrollment figure and the population contributing to each outcome is not explained. The record also does not give the allocation procedure or identify the roles covered by triple masking.

The registry lists two outcome measures and no statistical analyses. It does not report a multiplicity strategy, model choice, adjustment method, or statistical plan. It also provides no information in this record about adherence or how protocol deviations were treated. These omissions constrain assessment of the analysis and its reliability; they do not establish that the trial lacked a protocol or that the trial was not conducted as planned.

Safety reporting is limited to the listed at-risk and affected counts, a serious-event term, and no reported deaths count. The record does not provide a causal assessment or uncertainty around comparative safety. Overall, the registry permits description of the design and outcome definition, but not an independent evaluation of the primary outcome effect.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Investigational Multi-purpose Contact Lens Care Solution. — NCT01055613.
• Registry record last updated 2018-06-19; status last verified 2016-07.
• Results first posted 2016-08-31.
• 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

NCT01055613 is a completed, randomized, triple-masked, parallel study comparing Vistakon Investigational Multi-Purpose Solution I with ReNu MultiPlus Multi-Purpose Solution for contact lens wear. The registry records enrollment as 312, lists the phase as NA, and gives a start of 2009-11 and primary completion of 2010-05. The sponsor is Johnson & Johnson Vision Care, Inc.

The primary outcome is Slit Lamp Findings: the number of eyes with Grade 3 or higher findings for each lens at each assessment, over a three-month timeframe. The record describes a five-grade scale and defines the analysis population as subjects dispensed a solution during the study.

Numerical primary-outcome results and statistical analyses are not reported in the registry record. Safety entries report one serious adverse event among 200 at risk in the experimental group and none among 100 at risk in the comparator group. Other adverse events are reported as 0 in each group. The record lists Microbial Keratitis at 0.5% among the top serious terms, and deaths are not reported.