Skip to main content
OpenTrials
Completed

NCT Number: NCT02312544

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vold Vision

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTX-TP

Drug

OTX-TP and placebo drops

Timolol

Drug

Timolol drops and placebo punctum plug

Primary outcomes

  1. Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit

    Time frame: Days 57 to 63

  2. Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit

    Time frame: Days 87 to 93

  3. Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits

    Time frame: Days 57 to 63 and Days 87 to 93

  4. Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

    Time frame: Days 57 to 63 and Days 87 to 93

  5. Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

    Time frame: Days 57 to 63 and 87 to 93

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.