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)

Last updated: March 18, 2025
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

2

Condition

Ocular Hypertension

Stress

Circulation Disorders

Treatment

Durysta, Bimatoprost Intracameral Implant 10 µg

OTX-TIC high dose Travoprost Intracameral Implant

OTX-TIC low dose Travoprost Intracameral Implant

Clinical Study ID

NCT05335122
OTX-TIC-2020-201
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

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 atBaseline

  • Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion

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 theuse of adequate contraceptive methods during the length of the study

  • Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Study Design

Total Participants: 83
Treatment Group(s): 3
Primary Treatment: Durysta, Bimatoprost Intracameral Implant 10 µg
Phase: 2
Study Start date:
March 16, 2022
Estimated Completion Date:
January 24, 2025

Study 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.

Connect with a study center

  • Ocular Therapeutix, Inc.

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Irvine, California 92604
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Los Angeles, California 90013
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Pasadena, California 91107
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Petaluma, California 94954
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Redlands, California 92373
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Torrance, California 90505
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Ocular Therapeutiux, Inc.

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Rock Island, Illinois 61201
    United States

    Site Not Available

  • Ocular Therapeutix Inc

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Saint Joseph, Missouri 49085
    United States

    Site Not Available

  • Ocular Therapeutix Inc.

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Dover, New Jersey 07801
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Troy, New York 12108
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Ocular Therapeutiux, Inc.

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ocular Therapeutix Inc

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Austin, Texas 78701
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Dallas, Texas 75231
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    El Paso, Texas 79902
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Houston, Texas 77030
    United States

    Site Not Available

  • Ocular Therapeutix, Inc.

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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