Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

September 7, 2023 updated by: Glaukos Corporation

Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

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
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • John Berdahl, MD

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

Description

Inclusion Criteria:

  • Open angle glaucoma

Exclusion Criteria:

  • Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
  • Functionally significant visual field loss, including severe nerve fiber bundle defects.
  • Prior glaucoma surgery.
  • Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
  • Other ocular status conditions, etc.

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: Travoprost Intraocular Implant, high elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Drug: Travoprost Intraocular Implant, high elution
Surgical implant placed within the eye to elute travoprost.
Experimental: Travoprost Intraocular Implant, low elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Drug: Travoprost Intraocular Implant, low elution
Surgical implant placed within the eye to elute travoprost
Active Comparator: Timolol Maleate Ophthalmic Solution, 0.5%
Timolol, a beta blocker, will be dosed twice daily
Drug: Timolol Maleate Ophthalmic Solution, 0.5%
Instillation of one drop of timolol in the study eye twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP (mmHg) Change From Baseline at Week 12
Time Frame: 12 weeks
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe Adverse Events
Time Frame: Post-op through Month 36
The number and percent of subjects with severe adverse events in the study eye
Post-op through Month 36

Collaborators and Investigators

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

Sponsor

Glaukos Corporation

Investigators

  • Study Chair: Kerry Stephens, O.D., Glaukos Corporation

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)

March 29, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimated)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated during and/or analyzed during the current study are not publicly available at this time due to ongoing U.S. Food and Drug Administration review of a New Drug Application for the travoprost intraocular implant.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Glaucoma Open-angle

Clinical Trials on Travoprost Intraocular Implant, high elution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe