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Ocular Therapeutix begins phase 2 clinical trial for sustained release dexamethasone
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Ocular Therapeutix enrolled the first patient in a phase 2 clinical trial to evaluate the safety and efficacy of sustained-release dexamethasone to treat inflammatory dry eye disease, according to a press release.
A one-time bioresorbable intracanalicular plug will release dexamethasone to the ocular surface for up to 30 days.
The prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled clinical trial will enroll 40 subjects who show signs and symptoms of dry eye disease. The subjects will receive a placebo vehicle plug for 30 days to establish a baseline for the dexamethasone treatment. Qualified patients will then be randomized to sustained-release dexamethasone or a placebo vehicle plug.
Efficacy measures will include corneal and conjunctival staining, tear osmolarity, tear film break-up time, plug presence, ease of product use and visualization, and plug resorption after therapy, the release said.