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Completed
NCT05335122
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)
Conditions: Open Angle Glaucoma, Ocular Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 83
Sponsor: Ocular Therapeutix, Inc.
Location: Ocular Therapeutix, Inc. Dothan Alabama
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 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
Source: ClinicalTrials.gov (NCT05335122). StuddyBuddy aggregates publicly available trial information.