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

Launched by OCULAR THERAPEUTIX, INC. · Dec 4, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.