Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

September 14, 2021 updated by: Ocular Therapeutix, Inc.

A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension

The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.

Study Type

Interventional

Enrollment (Actual)

565

Phase

  • Phase 3

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

  • United States
    • California
      • Artesia, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Lakeland, Florida, United States
    • Georgia
      • Morrow, Georgia, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Missouri
      • Des Peres, Missouri, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • Austin, Texas, United States

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:

  • Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
  • IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

  • Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
  • A history of an inadequate response or no response to topical prostaglandin
  • Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-TP (sustained release travoprost) Intracanalicular Depot
Drug: Travoprost
Placebo Comparator: PV (Placebo Vehicle) Intracanalicular Depot
Other: Placebo Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean IOP
Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Mean IOP
Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Mean IOP
Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events
Time Frame: Through study completion, an average of 23 months
Number of Participants with Serious Adverse Events
Through study completion, an average of 23 months

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 (Actual)

November 7, 2016

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-16-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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