Statistics
Inferior corneal fluorescein, inferior corneal fluorescein
DRY EYE, SECONDARY
For each endpoint, change from baseline was calculated for each patient as week 12 (day 85) − baseline (day 1), such that a positive difference indicated a worsening of the dry eye sign or symptom. In addition, comparisons between active treatment and placebo were calculated as active −placebo, such that a negative result indicated a better score for the active treatment. Pre- to post-CAE change was calculated as post-CAE − pre-CAE. For the analysis of the endpoints, patients without a recorded value at the final day 85 visit had their observations imputed using Markov chain Monte Carlo imputation under the assumption of a missing-at-random mechanism using the ITT population. Inferior corneal fluorescein staining was summarized at week 12 pre-CAE to post-CAE change by treatment groups using continuous descriptive statistics. Analysis of the change from baseline used an analysis of covariance model adjusted for baseline inferior corneal fluorescein staining pre-CAE to post-CAE change and with treatment group as the explanatory variable. Changes from baseline for each treatment group in inferior corneal fluorescein staining were compared between 1 μg/mL PL9643 ophthalmic solution and placebo. Ocular discomfort was summarized at week 12 pre-CAE by treatment groups using continuous descriptive statistics. The type I error for secondary endpoints was not adjusted for multiplicity. Therefore, statistical significance for these endpoints, which was determined based on a 2-sided 