To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
OTX-TIC implant is injection in the anterior chamber of the eye
Ocular Therapeutix, Inc.
Petaluma, California, United States
Ocular Therapeutix, Inc.
Torrance, California, United States
Ocular Therapeutix, Inc
Roswell, Georgia, United States
Ocular Therapeutix, Inc.
Austin, Texas, United States
Ocular Treatment Emergent Adverse Events
All adverse events will be captured throughout the study
Time frame: Through study completion, 6 months
Efficacy Outcome
IOP measurements at 8 am
Time frame: Diurnal IOP [12 Week Visit]
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Ocular Therapeutix, Inc.
Racine, Wisconsin, United States