Status:
COMPLETED
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subject must be greater than or equal to 18 years of age at Screening.
- Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
- Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
- Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.
Exclusion
- Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
- Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
- Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of \>34 mm Hg.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01845038
Start Date
April 1 2013
End Date
May 1 2014
Last Update
December 12 2016
Active Locations (1)
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1
Umhlanga Hospital Medical Centre
Durban, South Africa