The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of \~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of \~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.
Umhlanga Hospital Medical Centre
Durban, South Africa
Mean IOP change from baseline
Time frame: 90 days
Visualization of OTX-TP punctum plug by subject
OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days.
Time frame: 90 days
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