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)

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.

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