NCT04747977

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Detailed description

Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	OTX-DED	0.2mg dexamethasone ophthalmic insert
DRUG	OTX-DED	0.3mg dexamethasone ophthalmic insert
DRUG	OTX-DED	Hydrogel vehicle ophthalmic insert

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-08-11
• Completion: 2021-09-22
• First posted: 2021-02-10
• Last updated: 2023-02-22
• Results posted: 2023-02-22

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study