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NCT04362670 Clinical Trial

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04362670
Other study ID # CLN-Protocol-0054
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 23, 2020
Est. completion date August 11, 2021

Study information
Verified date October 2023
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• OTX-CSI
OTX-CSI intracanalicular insert
Other:
• Placebo Vehicle
Hydrogel Vehicle intracanalicular insert

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
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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