To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
- Registration Number
- NCT04747977
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- Dry Eye Disease diagnosis
- VAS eye dryness severity score ≥ 40.
- Are unwilling to discontinue use of contact lenses
- Are unwilling to withhold use of artificial tears.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTX-DED 0.2mg OTX-DED Approximately 50 subjects OTX-DED 0.3mg OTX-DED Approximately 50 subjects Hydrogel Vehicle (HV) OTX-DED Approximately 50 subjects
- Primary Outcome Measures
Name Time Method Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). Change from baseline (Day 1) at Visit 4 (Day 15) The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15).
Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Ocular Therapeutix, Inc
🇺🇸Mission Hills, California, United States
Ocular Therapeutix
🇺🇸Poughkeepsie, New York, United States
Ocular Therapeutix, Inc.
🇺🇸League City, Texas, United States