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Prostaglandin Analog

Travoprost Intraocular Implants for Glaucoma

Phase 3
Waitlist Available
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with open-angle glaucoma or ocular hypertension
Zero to two preoperative ocular hypotensive medications
Must not have
Active corneal inflammation or edema
Retinal disorders not associated with glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing tiny devices placed inside the eye that release Travoprost slowly. It targets patients with high eye pressure due to open-angle glaucoma or ocular hypertension. Travoprost helps drain excess fluid from the eye, while Timolol reduces fluid production.

Who is the study for?
This trial is for people with a cup-to-disc ratio of 0.8 or less, who are on up to two glaucoma medications, and have been diagnosed with open-angle glaucoma or ocular hypertension. It's not for those with active corneal inflammation/edema or retinal disorders unrelated to glaucoma.
What is being tested?
The study compares two versions of a Travoprost-releasing eye implant (G2-TR) against Timolol eye drops in reducing high pressure inside the eyes caused by glaucoma or hypertension. Participants will be randomly assigned to receive one of these treatments.
What are the potential side effects?
Possible side effects may include discomfort at the implant site, redness, blurry vision, dry eyes, and potential risks associated with surgery like infection. The comparator Timolol could cause burning/stinging in eyes, fatigue, and breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with open-angle glaucoma or high eye pressure.
Select...
I am using up to two eye pressure-lowering medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active inflammation or swelling in my cornea.
Select...
I have a retinal disorder not related to glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Secondary study objectives
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative

Side effects data

From 2024 Phase 3 trial • 590 Patients • NCT03519386
8%
intraocular pressure increased
1%
Combined adverse events in Infections and Infestations SOC
1%
Combined adverse events in Cardiac Disorders SOC
1%
Combined adverse events in Psychiatric Disorders SOC
1%
Combined adverse events in Musculoskeletal and Connective Tissue Disorders SOC
1%
iritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Implant Group 1
Implant Group 2
Control Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Implant Group 2Experimental Treatment1 Intervention
G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Group II: Implant Group 1Experimental Treatment1 Intervention
G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Group III: Control GroupActive Control1 Intervention
Sham surgery + active-comparator eye drops
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G2-TR intraocular implant containing travoprost
2018
Completed Phase 3
~1150

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ocular hypertension include prostaglandin analogs (like Travoprost), beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. Prostaglandin analogs, such as Travoprost, work by increasing the outflow of aqueous humor through the uveoscleral pathway, thereby reducing intraocular pressure (IOP). Beta-blockers reduce aqueous humor production, while alpha agonists both decrease production and increase outflow. Carbonic anhydrase inhibitors also reduce aqueous humor production. For patients with ocular hypertension, managing IOP is crucial to prevent the progression to glaucoma, which can lead to vision loss. Treatments that increase aqueous humor outflow, like Travoprost, are particularly effective in lowering IOP and are a key component in preventing optic nerve damage.

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
8,778 Total Patients Enrolled
6 Trials studying Ocular Hypertension
1,407 Patients Enrolled for Ocular Hypertension
Kerry Stephens, ODStudy ChairGlaukos Corporation
4 Previous Clinical Trials
305 Total Patients Enrolled

Media Library

G2TR intraocular implant containing travoprost (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT03868124 — Phase 3
Ocular Hypertension Research Study Groups: Control Group, Implant Group 1, Implant Group 2
Ocular Hypertension Clinical Trial 2023: G2TR intraocular implant containing travoprost Highlights & Side Effects. Trial Name: NCT03868124 — Phase 3
G2TR intraocular implant containing travoprost (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868124 — Phase 3
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