The objectives of this study are twofold * To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) * To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
1 drop of AGN-195263 will be instilled in each eye twice daily.
1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
Time frame: 6 month visit
Change From Baseline in Tearfilm Break Up Time (TBUT)
For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for analysis
Time frame: Baseline (day 1) to 6 month visit
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