Status:
COMPLETED
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)
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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)
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05335122
Start Date
March 16 2022
End Date
January 24 2025
Last Update
March 21 2025
Active Locations (30)
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1
Ocular Therapeutix, Inc.
Dothan, Alabama, United States, 36301
2
Ocular Therapeutix, Inc.
Huntington Beach, California, United States, 92647
3
Ocular Therapeutix, Inc.
Irvine, California, United States, 92604
4
Ocular Therapeutix, Inc.
Los Angeles, California, United States, 90013