A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

August 13, 2026 updated by: Ocular Therapeutix, Inc.

A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Ocular Therapeutix, Inc.
    • California
      • Huntington Beach, California, United States, 92647
        • Ocular Therapeutix, Inc.
      • Irvine, California, United States, 92604
        • Ocular Therapeutix, Inc.
      • Los Angeles, California, United States, 90013
        • Ocular Therapeutix, Inc.
      • Pasadena, California, United States, 91107
        • Ocular Therapeutix, Inc.
      • Petaluma, California, United States, 94954
        • Ocular Therapeutix, Inc.
      • Redlands, California, United States, 92373
        • Ocular Therapeutix, Inc.
      • Torrance, California, United States, 90505
        • Ocular Therapeutix, Inc.
    • Florida
      • Clearwater, Florida, United States, 33761
        • Ocular Therapeutix, Inc.
      • Delray Beach, Florida, United States, 33484
        • Ocular Therapeutiux, Inc.
      • Fort Myers, Florida, United States, 33901
        • Ocular Therapeutix, Inc.
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Ocular Therapeutix, Inc.
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Ocular Therapeutix, Inc.
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Ocular Therapeutix Inc
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Ocular Therapeutix, Inc.
    • Missouri
      • Saint Joseph, Missouri, United States, 49085
        • Ocular Therapeutix, Inc.
      • St Louis, Missouri, United States, 63110
        • Ocular Therapeutix Inc.
    • New Jersey
      • Dover, New Jersey, United States, 07801
        • Ocular Therapeutix, Inc.
    • New York
      • Troy, New York, United States, 12108
        • Ocular Therapeutix, Inc.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Ocular Therapeutix, Inc.
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Ocular Therapeutiux, Inc.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Ocular Therapeutix, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Ocular Therapeutix Inc
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Ocular Therapeutix, Inc.
      • Philadelphia, Pennsylvania, United States, 19107
        • Ocular Therapeutix, Inc.
    • Texas
      • Austin, Texas, United States, 78701
        • Ocular Therapeutix, Inc.
      • Dallas, Texas, United States, 75231
        • Ocular Therapeutix, Inc.
      • El Paso, Texas, United States, 79902
        • Ocular Therapeutix, Inc.
      • Houston, Texas, United States, 77030
        • Ocular Therapeutix, Inc.
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Ocular Therapeutix, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Are 18 years of age or older at the time of screening
  • Provide written informed consent and are able to comply with all study requirements
  • Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
  • Have a negative pregnancy test result for women of childbearing potential at Baseline
  • Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

  • Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
  • Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
  • Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-TIC Low Dose
Travoprost Intracameral Implant low dose
Drug: OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
Experimental: OTX-TIC High Dose
Travoprost Intracameral Implant high dose
Drug: OTX-TIC high dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
Active Comparator: Durysta
Bimatoprost Intracameral Implant 10 µg
Drug: Durysta, Bimatoprost Intracameral Implant 10 µg
Durysta is injected into the anterior chamber of the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP Changes From Baseline in the Study Eye
Time Frame: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)
IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.
Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-TIC-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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