Status:
COMPLETED
Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% i...
Eligibility Criteria
Inclusion
- Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component).
- Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of
- ≥ 24mmHg at Hour 0 (T0) at Baseline Visit 1 and Baseline Visit 2 (Day 1)
- Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of:
- ≥ 22mmHg at (T0 + 4h) and (T0 + 8h) at Baseline Visit 1 (note: the same eye must meet the IOP eligibility criteria at all 4 baseline assessments)
- Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1 and Baseline Visit 2 (Day 1)
Exclusion
- Subject with any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
- Subject with mean baseline IOP \>34 mmHg in either eye at any time point during the Baseline Visits 1 or 2 (Day 1).
- Subject with a BCVA worse than 0.6 logMAR (20/80 Snellen) in either eye as measured using an ETDRS chart.
- Subject with a known or suspected allergy and/or hypersensitivity to travoprost, timolol, fluorescein or to any component of the study products.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02312544
Start Date
November 1 2014
End Date
December 1 2015
Last Update
December 14 2016
Active Locations (1)
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1
Vold Vision
Fayetteville, Arkansas, United States, 72704