Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis (NCT01119287), a randomized phase 4 study. The primary outcome is Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo.

2. Clinical Question

The study also included Patanol, but the stated primary endpoint description specifically identifies Maxidex versus placebo as the meaningful late-phase comparison. The registry’s brief summary says the study evaluated both active treatments against placebo during controlled allergen exposure. It does not report an endpoint estimate for either comparison, nor does it state whether the primary question was answered in a separate analysis outside the registry record. The study’s setting is important to interpretation: redness was assessed after exposure under controlled chamber conditions, not described as an assessment across everyday environmental exposures.

3. Trial Design

This was a Phase 4 randomized, double-masked, placebo-controlled, parallel-group study sponsored by Alcon Research. It was registered as completed, with a recorded enrollment of 180. The registry lists allergic conjunctivitis as the condition under study. The recorded study start was 2010-03 and primary completion was 2010-09.

Three groups are described: Maxidex, Patanol, and Tears Naturale II as placebo. The active treatments were ophthalmic formulations. The registry describes each group’s dosing as 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days, from Visit 4 through the morning of Visit 6. The primary outcome timeframe runs from baseline at Visit 3, before treatment, to Visit 6, Day 9 of treatment. On Visit 6, participants were dosed in the morning 30 minutes before entering the environmental exposure chamber.

Random allocation means treatment assignment was described as randomized, while double masking indicates that the record identifies the study as double-masked. The registry does not report how the random sequence was generated, how assignment was concealed, or which roles were masked. Those implementation details are not reported in the registry record. A parallel-group design compares groups assigned to different treatments rather than describing a crossover between treatments.

The environmental exposure chamber model was used to expose participants to controlled allergen levels. The record does not report the chamber allergen, detailed exposure procedures beyond the primary endpoint description, or the allocation ratio. It also does not report a statistical analysis plan. Although the registry describes the study as completed, completion status alone does not establish what analyses were performed or what the treatment effects were.

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 180 patients enrolled, 170 were identified as either ragweed allergic or cat allergic, randomized to one of three study treatments, and received at least one dose of study treatment. Ten additional patients identified as ragweed allergic participated in Visits 1 to 3 only, per protocol design.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of subjects with data available in the specific treatment group

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.

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo, measured over Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment).

The primary endpoint is the mean change from baseline in staff-assessed ocular redness, expressed as area under the curve from time zero to hour 10, abbreviated AUC (0-10). The measure combines ratings collected over the assessment period into a summary intended to represent redness over time. AUC can capture both the level and duration of an observed response; it is not simply a single rating at one time point.

Staff rated nasal and temporal areas of each eye on a scale from 0 (none) to 4 (extremely severe), with 0.5 unit steps permitted. At each time point, the AUC was based on the peak redness score, defined as the maximum of four redness areas. The assessment included pre-treatment, chamber assessments through hour 3, and clinic assessments from 3.5 through hour 10. The measure was selected to evaluate a late-phase effect, and the registry identifies Maxidex versus placebo as the meaningful comparison for that purpose.

For a continuous endpoint, a group mean describes the average measured change, while the standard deviation describes spread among observed values. AUC is reported in hours x units on a scale. The record gives the endpoint definition and timeframe but does not report the group means, standard deviations, mean change difference, or confidence interval. Thus, the endpoint’s design and interpretation can be described, but its observed treatment contrast cannot be quantified from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the mean represent?

The primary measure is continuous: each participant can contribute an AUC value, and a group mean summarizes the average value for participants included in that group’s endpoint analysis. The endpoint is defined as mean change from baseline. In general, change scores compare a participant’s measurement after treatment with a baseline measurement; how the difference is calculated depends on the stated convention. That convention is not reported in the registry record. A mean is useful for describing the center of a continuous outcome, but it does not show how much individual observations vary.

The endpoint combines staff-assessed redness over time. Ratings were taken from four areas, and the highest of those ratings at each time point was used in the AUC computation. Integrating observations over the stated time range can represent a pattern across the assessment period rather than relying on one rating. This summary also means that the endpoint’s interpretation depends on the timing and measurement procedures described in the record. It does not by itself reveal individual trajectories or how ratings differed at particular times.

Why is the standard deviation relevant?

The registry identifies standard deviation as the dispersion measure for the primary endpoint. In general, standard deviation describes how spread out observations are around their group mean. It is not the same as a confidence interval: the standard deviation describes participant-level variability, whereas a confidence interval describes uncertainty in an estimated quantity. A standard deviation can help readers understand how much individual outcomes vary, but it does not establish the precision of a comparison on its own.

The registry record does not give the endpoint’s group standard deviations or means. Therefore, the observed spread and the precision of a Maxidex-versus-placebo contrast cannot be evaluated. A difference in means, if reported, would describe an average contrast; its uncertainty would still matter when judging how precisely that contrast was estimated.

What would an inferential comparison add?

A treatment comparison typically estimates a contrast between groups and assesses uncertainty using a confidence interval or a statistical test. A confidence interval helps distinguish an estimate that is precise from one that remains compatible with a broad range of possible effects. A p-value, when used, describes how unusual data at least as incompatible with a specified null hypothesis would be under the test’s assumptions. It is not a measure of the probability that a treatment works, and it does not convey the size or clinical relevance of an effect.

No inferential result for the primary comparison is reported in the registry record. The registry lists zero analyses. The statistical plan, choice of test, covariate adjustment, handling of repeated measurements, and any interim analyses are not reported in the registry record. Without those details and the numerical endpoint summaries, no sponsor analysis can be compared with a recalculation, and no unadjusted estimate can be reconstructed.

Why can the chamber setting matter?

In general, a controlled exposure model can standardize the conditions under which an outcome is measured. That can make comparisons under those conditions easier to interpret, while limiting how directly the findings represent outcomes in other settings. Here, the registry describes controlled allergen levels, a chamber assessment through hour 3, and clinic assessments thereafter through hour 10. The record does not state the allergen details or provide results by assessment time. The AUC is therefore the stated summary for the late-phase question, but the record does not permit inspection of the pattern that produced it.

What is the role of sample-size planning?

In general, sample-size planning estimates how many participants per arm might be needed to detect a prespecified effect under stated assumptions. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of the observed effect. These are planning assumptions, not trial results. A planning illustration is not observed power and does not show that an effect was detected.

The registry does not report the observed primary endpoint effect needed to interpret such planning illustrations, nor does it report the trial’s own sample-size justification. The planning description also does not establish the actual allocation ratio or actual endpoint sample sizes. Those details are not reported in the registry record. Because the primary summaries are absent, the planning assumptions cannot be used to infer the trial’s result or its precision.

Overall, the record supports explanation of the endpoint’s measurement and of general statistical concepts, but not a numerical reconstruction. The absence of results is distinct from a null result: without an estimate and its uncertainty, there is no basis in this record to state that the groups were similar or different.

10. Multiplicity, Missing Data and Analysis Populations

The study describes three treatment groups and reports two outcome measures, but the registry record does not provide a complete statistical analysis plan. It does not state which outcomes were designated primary beyond the endpoint, how many treatment comparisons were planned, or whether any adjustment for multiple comparisons was intended. Multiplicity refers generally to the increased chance of a chance-positive finding when many outcomes or contrasts are tested. Whether and how that issue was addressed is not reported in the registry record.

The primary endpoint description identifies Maxidex versus placebo as the meaningful late-phase comparison. The brief summary also describes evaluating Patanol compared with placebo. The record does not say whether these comparisons were included in one testing hierarchy, whether the Patanol comparison was secondary, or whether the same endpoint was assessed for each group. No results or analysis entries are available to clarify these points.

Missing-data handling is also not described. The registry defines the outcome population as subjects with data available in the specific treatment group, but does not report how many participants contributed endpoint data in each group, why data might be missing, or how missing measurements were handled. It does not state whether the analysis used all randomized participants, participants who completed treatment, or another analysis population. Those details are not reported in the registry record.

Consequently, readers cannot determine from the record whether outcome availability differed by group or how such differences might affect the comparison. The recorded enrollment is not a substitute for group-specific endpoint denominators. The registry also does not report the statistical plan, interim analyses, or sensitivity analyses. These omissions limit assessment of the robustness and multiplicity control of any treatment-effect claim; the available record does not itself report such a claim.

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 non-serious adverse event terms

The registry lists serious adverse events as affecting 0 participants in each group: Maxidex, with 57 at risk; Patanol, with 55 at risk; and Tears Naturale II, with 58 at risk. These are the group-specific figures recorded for serious adverse events. They describe the registry entries and should not be interpreted as proof that serious events could not occur or that there was no safety risk.

For other adverse events, the registry lists 13 participants affected in the Maxidex group, 7 in the Patanol group, and 7 in the Tears Naturale II group. The corresponding groups at risk are 57, 55, and 58. These counts are descriptive. The record does not provide event terms, severity details, timing, or a statistical comparison for these other events. It also does not report whether a participant could have experienced more than one event or how the counts were defined beyond participants affected.

Deaths are not reported in the registry record. The empty listing of top serious-event terms does not add detail about the event counts. Differences in these descriptive counts cannot by themselves establish a causal treatment effect, particularly without details about event ascertainment, follow-up, or analysis.

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

The registry establishes that a randomized, double-masked, placebo-controlled, parallel-group study was conducted to evaluate Maxidex and Patanol in allergic conjunctivitis under controlled allergen exposure. It gives the primary endpoint definition, describes the treatment schedules, and records selected adverse-event counts. This is useful for understanding the question and the measurement strategy.

It does not establish the result of the primary efficacy comparison. The numerical mean changes, standard deviations, between-group estimate, confidence interval, and p-value are not reported in the registry record. No direction or size of the Maxidex-versus-placebo contrast can therefore be stated. The absence of reported efficacy results is not evidence that the treatments had identical outcomes, and it is not evidence that either active treatment had a particular effect.

The endpoint was measured in an environmental exposure chamber model, with clinic assessments continuing after the chamber period. Any finding from such a model would pertain directly to the conditions and outcome measured in the study. Generalizing beyond those conditions would require evidence and context not contained in this registry record. The record does not provide results by time point or describe longer-term outcomes.

The adverse-event counts offer limited descriptive safety information. They do not establish comparative safety, because the record lacks event details and inferential analyses. The recorded zeros for serious adverse events should be read as counts in the listed groups, not as a guarantee about risk or as proof of no serious events in other circumstances.

Accordingly, the defensible conclusion is narrow: the registry describes the study design and measurement, but does not report enough statistical outcome information to quantify or assess the primary treatment contrast. A clinical or statistical conclusion about efficacy or comparative safety cannot be drawn from the information recorded.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of a study that defines a continuous, time-integrated endpoint in a controlled exposure model. The ocular-redness outcome was not a single assessment: the AUC uses peak scores across four areas at each time point over the stated assessment period. That choice reflects a specific estimand—the average change in a summary of redness over time—and differs from asking about redness at one particular hour.

The record also illustrates why endpoint definitions and numerical results need to be read together. A detailed scale, schedule, and AUC definition clarify what was intended to be measured. Without the group summaries and uncertainty estimates, however, readers cannot quantify the treatment contrast, judge its precision, or evaluate whether the observed difference might be compatible with a wide range of effects.

The study’s three-group design raises interpretive questions about which comparisons were central and how multiple comparisons were handled. The registry identifies Maxidex versus placebo as the meaningful primary comparison for the late-phase endpoint, but does not report the analysis plan or outcomes. Those omissions make it difficult to assess how the stated question related to other possible comparisons.

Finally, enrollment and endpoint analysis populations are not interchangeable. The registry records overall enrollment and defines the outcome population by data availability in each treatment group, but does not report the endpoint denominators. This distinction matters in any clinical trial: the analysis population and missing-data handling influence how estimates should be interpreted. Here, those details and the primary numerical results are 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 most consequential limitation for statistical interpretation is that the registry record does not report the primary endpoint results. Group means, standard deviations, the treatment contrast, confidence intervals, and p-values are absent. Without them, neither the effect’s direction and magnitude nor its precision can be assessed. The registry lists no analyses, so a reported sponsor analysis cannot be evaluated against a recalculation from summary statistics.

The endpoint population is described as participants with available data in each group, but group-specific endpoint denominators and missing-data procedures are not reported in the registry record. The record also does not explain the change-score convention, the analysis model, adjustment variables, or handling of repeated measurements. These omissions prevent assessment of the statistical assumptions and robustness of the primary comparison.

The registry does not report the random-sequence method, allocation concealment, specific masking procedures, allocation ratio, sample-size justification, or interim analyses. It also does not describe multiplicity control. The chamber allergen and further exposure procedures are not detailed beyond the information in the endpoint description. These are limitations of the available record; they should not be taken to mean that the trial necessarily lacked such procedures or analyses.

Safety interpretation is limited by the absence of adverse-event terms and detail for other events, along with the lack of reported deaths. The posted counts are descriptive and do not establish comparative risks. The controlled exposure model and the specified endpoint also constrain interpretation to the conditions measured; the registry does not report results for other settings or longer-term follow-up.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis — NCT01119287.
• Registry record last updated 2014-02-28; status last verified 2013-03.
• Results first posted 2013-03-06.
• 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

NCT01119287 is a completed Phase 4 randomized, double-masked, placebo-controlled, parallel-group study sponsored by Alcon Research. It studied allergic conjunctivitis using Maxidex, Patanol, and Tears Naturale II as placebo, with enrollment recorded as 180. The primary endpoint was mean change from baseline in staff-assessed ocular redness AUC (0-10), with Maxidex versus placebo identified as the meaningful late-phase comparison.

The registry describes the endpoint scale, assessment schedule, and treatment regimens. It records serious adverse events affecting 0 participants in each group and other adverse events affecting 13 in Maxidex, 7 in Patanol, and 7 in Tears Naturale II. Deaths are not reported in the registry record.

Numerical primary efficacy results, group-specific endpoint sample sizes, inferential analyses, and detailed analysis methods are not reported in the registry record. The record therefore permits a description of the trial question and measurement, but not a quantitative interpretation of its primary comparison.