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Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

Dry Eye Disease Clinical Trial

Official title:
A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)

Clinical Trial Summary

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Clinical Trial Description

Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04362670
Study type Interventional
Source Ocular Therapeutix, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 23, 2020
Completion date August 11, 2021
View Details
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