Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT04747977
  4. Details
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)
See also
  Status Clinical Trial Phase
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A