Dry Eye Disease Clinical Trial
Official title:
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)
Verified date | October 2023 |
Source | Ocular Therapeutix, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 153 |
Est. completion date | August 11, 2021 |
Est. primary completion date | August 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ocular Therapeutix, Inc. | Cleveland | Ohio |
United States | Ocular Therapeutix, Inc. | Cranberry Township | Pennsylvania |
United States | Ocular Therapeutix, Inc. | Delray Beach | Florida |
United States | Ocular Therapeutix, Inc. | El Paso | Texas |
United States | Ocular Therapeutix, Inc. | Garden Grove | California |
United States | Ocular Therapeutix, Inc. | Inglewood | California |
United States | Ocular Therapeutix, Inc. | Kansas City | Missouri |
United States | Ocular Therapeutix, Inc. | Lake Villa | Illinois |
United States | Ocular Therapeutix | Lakeway | Texas |
United States | Ocular Therapeutix, Inc. | Largo | Florida |
United States | Ocular Therapeutix, Inc. | Memphis | Tennessee |
United States | Ocular Therapeutix, Inc. | Mission Hills | California |
United States | Ocular Therapeutix, Inc. | Murray | Utah |
United States | Ocular Therapeutix | Saint Louis | Missouri |
United States | Ocular Therapeutix, Inc | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Ocular Therapeutix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | From Screening to Study Exit, approximately 156 days. | |
Primary | Schirmer Test Score, CFB at Week 12 | A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm). | Change from Baseline at Week 12 |
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