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NCT04747977 Clinical Trial

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

Dry Eye Clinical Trial

Official title:
A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04747977
Other study ID # OTX-DED-2020-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 12, 2021
Est. completion date September 22, 2021

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

Clinical Trial Summary

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

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 information / eligibility
Status Completed
Enrollment 172
Est. completion date September 22, 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 = 40. 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-DED
0.2mg dexamethasone ophthalmic insert
• OTX-DED
0.3mg dexamethasone ophthalmic insert
• OTX-DED
Hydrogel vehicle ophthalmic insert

Locations
Country Name City State
United States Ocular Therapeutix, Inc. Cranberry Township Pennsylvania
United States Ocular Therapeutix, Inc. Delray Beach Florida
United States Ocular Therapeutix, Inc. Indianapolis Indiana
United States Ocular Therapeutix Inglewood California
United States Ocular Therapeutix Kansas City Missouri
United States Ocular Therapeutix, Inc. Largo Florida
United States Ocular Therapeutix, Inc. League City Texas
United States Ocular Therapeutix, Inc. Memphis Tennessee
United States Ocular Therapeutix, Inc Mission Hills California
United States Ocular Therapeutix, Inc. Newport Beach California
United States Ocular Therapeutix Poughkeepsie New York
United States Ocular Therapeutix, Inc. Raleigh North Carolina
United States Ocular Therapeutix, Inc. Saint Louis Missouri
United States Ocular Therapeutix, Inc. Santa Ana California
United States Ocular Therapeutix Warrenville Illinois

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 Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). 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.		 Change from baseline (Day 1) at Visit 4 (Day 15)
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