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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ocular Therapeutix, Inglewood, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTX-DED

Drug

0.2mg dexamethasone ophthalmic insert

Primary outcomes

Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).

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

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.

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 10, 2021
Registry last updated: Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed