Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
- Registration Number
- NCT04362670
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Dry eye disease diagnosis
- VAS eye dryness severity score ≥ 30.
- Are unwilling to discontinue use of contact lenses
- Are unwilling to withhold use of artificial tears.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HV Placebo Vehicle Cohort 2: Formulation 2B HV-2 Placebo Vehicle Cohort 2: Formulation 3 OTX-CSI-Cohort 1 OTX-CSI Formulation 2A-.36 mg OTX-CSI-Cohort 2 OTX-CSI Formulation 1- .36 mg OTX-CSI- Cohort 2 OTX-CSI Formulation 2A- .36 mg
- Primary Outcome Measures
Name Time Method Number of Subjects With At Least One (1) Treatment Emergent Adverse Event From Screening to Study Exit, approximately 156 days. Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Schirmer Test Score, CFB at Week 12 Change from Baseline at Week 12 A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Ocular Therapeutix, Inc
🇺🇸Saint Louis, Missouri, United States
Ocular Therapeutix
🇺🇸Lakeway, Texas, United States
Ocular Therapeutix, Inc.
🇺🇸Murray, Utah, United States