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)

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: Active, not recruiting
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: OTX-TIC low dose Travoprost Intracameral Implant; Drug: OTX-TIC high dose Travoprost Intracameral Implant; Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

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 (Estimated): 105
• Phase: Phase 2

Contacts and Locations

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.
    • Saint 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

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

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-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
Efficacy Outcome: IOP changes from Baseline	IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye	Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]

Collaborators and Investigators

• Sponsor: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 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 (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Travoprost; Bimatoprost
• 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