Dry Eye Disease Clinical Trial
Official title:
A Single-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of iNexin™ Eye Drops Compared to Vehicle in Subjects With Dry Eye Disease
The primary objective of this study is to evaluate the safety and tolerability of iNexin™ The secondary objective is to compare the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.
The clinical hypothesis for this study is that iNexin™ demonstrates safety and tolerability in subjects with DED and can be evaluated for further safety and efficacy measures compared to vehicle. This is a Phase 1b single-center, randomized, double masked, vehicle controlled clinical study to assess the safety and exploratory efficacy of iNexin™ compared to vehicle in subjects with Dry Eye Disease. A total of 36 subjects, at least 18 years of age, with a subject-reported history of DED in both eyes and meeting all other study eligibility criteria will be randomized to receive treatment with iNexin™ or vehicle. An individual subject's participation time is expected to be approximately 24 days. 36 eligible subjects will be randomized in a 2:1 allocation for each of three concentrations of iNexin™ to Vehicle, to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). There will also be a 1-day post-final dose follow-up visit (Visit 5). During a 7-day study run-in period prior to randomization (from Visit 1 to the evening before Visit 2), all subjects will receive Vehicle eye drops (Vehicle) bilaterally at the same dosing frequency as iNexin™ (BID). ;
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