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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

NCT ID: NCT02312544

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OTX-TP treatment

OTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately

Group Type ACTIVE_COMPARATOR

OTX-TP

Intervention Type DRUG

OTX-TP and placebo drops

Timolol control

Timolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV).

Group Type ACTIVE_COMPARATOR

Timolol

Intervention Type DRUG

Timolol drops and placebo punctum plug

Interventions

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OTX-TP

OTX-TP and placebo drops

Intervention Type DRUG

Timolol

Timolol drops and placebo punctum plug

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vold Vision

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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OTX-13-004

Identifier Type: -

Identifier Source: org_study_id