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

Last updated: December 13, 2016
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

2

Condition

Glaucoma

Circulation Disorders

Ocular Hypertension

Treatment

N/A

Clinical Study ID

NCT02312544
OTX-13-004
  • Ages > 18
  • All Genders

Study 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% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.

Eligibility Criteria

Inclusion

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 meetthe IOP eligibility criteria at all 4 baseline assessments)

  • Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1and Baseline Visit 2 (Day 1)

Exclusion

Exclusion Criteria:

  • Subject with any form of glaucoma other than open angle glaucoma (with or without apigment dispersion or pseudoexfoliation component).

  • Subject with mean baseline IOP >34 mmHg in either eye at any time point during theBaseline Visits 1 or 2 (Day 1).

  • Subject with a BCVA worse than 0.6 logMAR (20/80 Snellen) in either eye as measuredusing 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.

Study Design

Total Participants: 72
Study Start date:
November 01, 2014
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Vold Vision

    Fayetteville, Arkansas 72704
    United States

    Site Not Available

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