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

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)

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: OTX-DED; Drug: OTX-DED; Drug: OTX-DED

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Inglewood, California, United States, 90301
      • Ocular Therapeutix
    • Mission Hills, California, United States, 91345
      • Ocular Therapeutix, Inc
    • Newport Beach, California, United States, 92663
      • Ocular Therapeutix, Inc.
    • Santa Ana, California, United States, 92705
      • Ocular Therapeutix, Inc.
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Ocular Therapeutix, Inc.
    • Largo, Florida, United States, 33773
      • Ocular Therapeutix, Inc.
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • Ocular Therapeutix
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ocular Therapeutix, Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Ocular Therapeutix
    • Saint Louis, Missouri, United States, 63131
      • Ocular Therapeutix, Inc.
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Ocular Therapeutix
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Ocular Therapeutix, Inc.
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Ocular Therapeutix, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Ocular Therapeutix, Inc.
  • Texas
    • League City, Texas, United States, 77573
      • Ocular Therapeutix, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTX-DED 0.2mg; Approximately 50 subjects	Drug: OTX-DED; 0.2mg dexamethasone ophthalmic insert; Drug: OTX-DED; 0.3mg dexamethasone ophthalmic insert; Drug: OTX-DED; Hydrogel vehicle ophthalmic insert
Experimental: OTX-DED 0.3mg; Approximately 50 subjects	Drug: OTX-DED; 0.2mg dexamethasone ophthalmic insert; Drug: OTX-DED; 0.3mg dexamethasone ophthalmic insert; Drug: OTX-DED; Hydrogel vehicle ophthalmic insert
Placebo Comparator: Hydrogel Vehicle (HV); Approximately 50 subjects	Drug: OTX-DED; 0.2mg dexamethasone ophthalmic insert; Drug: OTX-DED; 0.3mg dexamethasone ophthalmic insert; Drug: OTX-DED; Hydrogel vehicle ophthalmic insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: dexamethasone ophthalmic insert
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: OTX-DED-2020-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No