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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ocular Therapeutix, Inc.
Dothan, Alabama, United States
Ocular Therapeutix, Inc.
Huntington Beach, California, United States
Ocular Therapeutix, Inc.
Irvine, California, United States
Ocular Therapeutix, Inc.
Los Angeles, California, United States
Ocular Therapeutix, Inc.
Pasadena, California, United States
Ocular Therapeutix, Inc.
Petaluma, California, United States
Ocular Therapeutix, Inc.
Redlands, California, United States
Ocular Therapeutix, Inc.
Torrance, California, United States
Ocular Therapeutix, Inc.
Clearwater, Florida, United States
Ocular Therapeutiux, Inc.
Delray Beach, Florida, United States
Start Date
March 16, 2022
Primary Completion Date
January 24, 2024
Completion Date
January 24, 2025
Last Updated
March 21, 2025
83
ACTUAL participants
OTX-TIC low dose Travoprost Intracameral Implant
DRUG
OTX-TIC high dose Travoprost Intracameral Implant
DRUG
Durysta, Bimatoprost Intracameral Implant 10 µg
DRUG
Lead Sponsor
Ocular Therapeutix, Inc.
NCT07396441
NCT07390890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05902871