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)
Overview
- Phase
- Phase 1
- Intervention
- OTX-CSI
- Conditions
- Dry Eye Disease
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 153
- Locations
- 3
- Primary Endpoint
- Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Dry eye disease diagnosis
- •VAS eye dryness severity score ≥ 30.
Exclusion Criteria
- •Are unwilling to discontinue use of contact lenses
- •Are unwilling to withhold use of artificial tears.
Arms & Interventions
OTX-CSI-Cohort 1
Formulation 2A-.36 mg
Intervention: OTX-CSI
OTX-CSI-Cohort 2
Formulation 1- .36 mg
Intervention: OTX-CSI
HV
Cohort 2: Formulation 2B
Intervention: Placebo Vehicle
OTX-CSI- Cohort 2
Formulation 2A- .36 mg
Intervention: OTX-CSI
HV-2
Cohort 2: Formulation 3
Intervention: Placebo Vehicle
Outcomes
Primary Outcomes
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Time Frame: 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
Time Frame: 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).