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Prostaglandin Analog

Travoprost Implant vs Timolol Drops 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
Zero to three preoperative ocular hypotensive medications
Diagnosed with open-angle glaucoma or ocular hypertension.
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 small devices placed inside the eye that slowly release a medication called travoprost. It aims to help people with open-angle glaucoma or ocular hypertension by lowering their eye pressure. The study compares these implants to another treatment to see which works better and is safer.

Who is the study for?
This trial is for people with open-angle glaucoma or ocular hypertension. Participants can have a cup-to-disc ratio of up to 0.8 and may be using up to three medications to lower eye pressure. Those with active corneal inflammation, edema, or retinal disorders unrelated to glaucoma cannot join.
What is being tested?
The study is testing two versions of a travoprost-releasing intraocular implant against Timolol Maleate Ophthalmic Solution (a standard treatment) in reducing high eye pressure caused by glaucoma or hypertension. It's a Phase III trial where one group gets the implants and another uses timolol drops.
What are the potential side effects?
Possible side effects include discomfort from the sham surgery or implant procedure, potential irritation from the eye drops, and any typical risks associated with intraocular devices such as infection or changes in vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using up to 3 eye pressure-lowering medications.
Select...
I have been diagnosed with open-angle glaucoma or high eye pressure.

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 that is 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

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

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
Common treatments for Ocular Hypertension include prostaglandin analogs like Travoprost, which increase the outflow of aqueous humor, thereby reducing intraocular pressure (IOP). This is particularly important as elevated IOP is a major risk factor for glaucoma. Other treatments include beta-blockers, which decrease aqueous humor production, and alpha agonists, which both decrease production and increase outflow. Carbonic anhydrase inhibitors also reduce aqueous humor production. Understanding these mechanisms helps in choosing the most effective treatment with minimal side effects, tailored to the patient's specific needs.
Bimatoprost effects on aqueous humor dynamics in monkeys.

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
8,748 Total Patients Enrolled
Kerry Stephens, O.D.Study ChairGlaukos Corporation
4 Previous Clinical Trials
1,229 Total Patients Enrolled

Media Library

G2TR intraocular implant containing travoprost (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT03519386 — Phase 3
Open-Angle Glaucoma Research Study Groups: Implant Group 1, Implant Group 2, Control Group
Open-Angle Glaucoma Clinical Trial 2023: G2TR intraocular implant containing travoprost Highlights & Side Effects. Trial Name: NCT03519386 — Phase 3
G2TR intraocular implant containing travoprost (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03519386 — Phase 3
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