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

Ocular Therapeutix, Inc.172 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Dry Eye

Interventions

OTX-DEDDRUG

0.2mg dexamethasone ophthalmic insert

OTX-DEDDRUG

0.3mg dexamethasone ophthalmic insert

OTX-DEDDRUG

Hydrogel vehicle ophthalmic insert

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Ocular Therapeutix

Inglewood, California, United States

Ocular Therapeutix, Inc

Mission Hills, California, United States

Ocular Therapeutix, Inc.

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline (Day 1) at Visit 4 (Day 15)

Data from ClinicalTrials.gov

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