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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing two different intraocular implants to see if either is more effective than Timolol Maleate Ophthalmic Solution in reducing intraocular pressure in subjects with open-angle glaucoma or ocular hypertension.

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.Check my eligibility

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.See study design

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

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I am using up to 3 eye pressure-lowering medications.

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I have been diagnosed with open-angle glaucoma or high eye pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor

65 Previous Clinical Trials

8,450 Total Patients Enrolled

5 Trials studying Ocular Hypertension

1,167 Patients Enrolled for Ocular Hypertension

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

Ocular Hypertension Research Study Groups: Implant Group 1, Implant Group 2, Control Group

Ocular Hypertension 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted into the study at this time?

"The information available on clinicaltrials.gov suggests that this particular trial is not presently looking for new patients. Although the trial's most recent update was on April 29th, 2021, the study is not actively recruiting at this time. There are, however, 111 other trials that are currently recruiting patients."

Answered by AI

What prior research has been conducted on the G2TR intraocular implant that contains the drug travoprost?

"At the moment, there are 4 clinical trials underway for the G2TR intraocular implant containing travoprost. These 4 trials are all in Phase 3. Most of the studies for the G2TR intraocular implant are taking place in Las Vegas, Nevada, but there are 4 other locations running trials for this treatment."

Answered by AI

Does the G2TR intraocular implant have FDA approval for travoprost?

"The G2TR intraocular implant, which is currently in Phase 3 clinical trials, has shown some efficacy in past studies and has received a score of 3 for safety."

Answered by AI

Recent research and studies

Annals of MedicineJournal

Sustained Release Glaucoma Therapies: Novel Modalities for Overcoming Key Treatment Barriers Associated with Topical Medications

Belamkar, Aditya, Alon Harris, Ryan Zukerman, Brent Siesky, Francesco Oddone, Alice Verticchio Vercellin, and Thomas A. Ciulla. 2022. “Sustained Release Glaucoma Therapies: Novel Modalities for Overcoming Key Treatment Barriers Associated with Topical Medications”. Annals of Medicine. Informa UK Limited. doi:10.1080/07853890.2021.1955146.

clinicaltrials.govStudy

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

2018. "Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519386.

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