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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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