NCT04362670

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OTX-CSI	OTX-CSI intracanalicular insert
OTHER	Placebo Vehicle	Hydrogel Vehicle intracanalicular insert

Timeline

• Start date: 2020-04-23
• Primary completion: 2021-08-11
• Completion: 2021-08-11
• First posted: 2020-04-27
• Last updated: 2023-11-14
• Results posted: 2023-11-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study