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)
Overview
- Phase
- Phase 2
- Intervention
- OTX-TIC low dose Travoprost Intracameral Implant
- Conditions
- Open Angle Glaucoma
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 83
- Locations
- 4
- Primary Endpoint
- Efficacy Outcome: IOP changes from Baseline
- Status
- Completed
- Last Updated
- last year
Overview
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 (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.
Investigators
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
Arms & Interventions
OTX-TIC Low Dose
Travoprost Intracameral Implant low dose
Intervention: OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC High Dose
Travoprost Intracameral Implant high dose
Intervention: OTX-TIC high dose Travoprost Intracameral Implant
Durysta
Bimatoprost Intracameral Implant 10 µg
Intervention: Durysta, Bimatoprost Intracameral Implant 10 µg
Outcomes
Primary Outcomes
Efficacy Outcome: IOP changes from Baseline
Time Frame: 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]
IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye