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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
OTX-TIC implant is injected into the anterior chamber of the eye.
OTX-TIC implant is injected into the anterior chamber of the eye.
Durysta is injected into the anterior chamber of the eye.
IOP Changes From Baseline in the Study Eye
IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.
Time frame: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 20 more locations