Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

December 8, 2016 updated by: Ocular Therapeutix, Inc.

A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility 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

The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa
        • Umhlanga Hospital Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be greater than or equal to 18 years of age at Screening.
  • Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
  • Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
  • Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

  • Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
  • Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
  • Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-TPa
OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of ~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops
OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
Experimental: OTX-TPb
OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of ~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops
OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
Active Comparator: Timolol
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months.
Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean IOP change from baseline
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of OTX-TP punctum plug by subject
Time Frame: 90 days
OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days.
90 days

Other Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-12-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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