Clinical Study Comparing Two Models of a Travoprost Intraocular Implant

September 7, 2023 updated by: Glaukos Corporation

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR-063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical Timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Study Type

Interventional

Enrollment (Actual)

560

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 Contact

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Center for Sight

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:

  • Diagnosed with open-angle glaucoma or ocular hypertension
  • C/D ratio ≤ 0.8
  • Zero to two preoperative ocular hypotensive medications

Exclusion Criteria:

  • Active corneal inflammation or edema
  • Retinal disorders not associated with glaucoma

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
Active Comparator: Control Group
Sham surgery + active-comparator eye drops
Drug: Sham surgery + active-comparator eye drops
Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Other Names:
  • Control Group
Experimental: Implant Group 1
G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Combination product: G2-TR intraocular implant containing travoprost
Provided in Arm/Group descriptions
Other Names:
  • Implant Group
Experimental: Implant Group 2
G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Combination product: G2-TR intraocular implant containing travoprost
Provided in Arm/Group descriptions
Other Names:
  • Implant Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Time Frame: 3 Months

Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3.

Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
Time Frame: 12 Months
Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit
12 Months

Collaborators and Investigators

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

Sponsor

Glaukos Corporation

Investigators

  • Study Chair: Kerry Stephens, OD, 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)

September 17, 2018

Primary Completion (Actual)

June 10, 2022

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 8, 2019

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-012

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 Ocular Hypertension

Clinical Trials on Sham surgery + active-comparator eye drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe