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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is comparing two different devices for reducing pressure in the eye for people with glaucoma or ocular hypertension.
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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with open-angle glaucoma or high eye pressure.
Select...
I am using up to two eye pressure-lowering medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Secondary outcome measures
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
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
Find a Location
Who is running the clinical trial?
Glaukos CorporationLead Sponsor
65 Previous Clinical Trials
8,480 Total Patients Enrolled
5 Trials studying Ocular Hypertension
1,197 Patients Enrolled for Ocular Hypertension
Kerry Stephens, ODStudy ChairGlaukos Corporation
4 Previous Clinical Trials
305 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active inflammation or swelling in my cornea.I have been diagnosed with open-angle glaucoma or high eye pressure.I have a retinal disorder not related to glaucoma.I am using up to two eye pressure-lowering medications.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Implant Group 1
- Group 3: Implant Group 2
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has G2TR intraocular implant containing travoprost received FDA approval?
"G2TR intraocular implant containing travoprost is suspected to be safe as it is a Phase 3 trial- meaning that while there is data supporting efficacy, there are also multiple rounds of data indicating safety."
Answered by AI
Can you tell me what other medical studies have been done that are similar to this one involving G2TR intraocular implant containing travoprost?
"There are 4 G2TR intraocular implant containing travoprost trials ongoing, with the majority taking place in Las Vegas. However, there are also clinical studies happening in 4 other locations."
Answered by AI
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