Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
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|ClinicalTrials.gov Identifier: NCT02815293|
Recruitment Status : Terminated
First Posted : June 28, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: AGN-195263 Drug: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye|
|Actual Study Start Date :||September 30, 2016|
|Actual Primary Completion Date :||June 21, 2017|
|Actual Study Completion Date :||June 21, 2017|
1 drop of AGN-195263 will be instilled in each eye twice daily.
|Placebo Comparator: Vehicle||
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) [ Time Frame: 6 month visit ]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.
- Change From Baseline in Tearfilm Break Up Time (TBUT) [ Time Frame: Baseline (day 1) to 6 month visit ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815293
|Study Director:||Medical Director||Allergan|