What side effects are associated with this type of intervention?

Common treatments for ocular hypertension that increase the outflow of aqueous humor include prostaglandin analogs like Travoprost. Known side effects of these treatments can include eye redness, eyelash growth, changes in iris pigmentation, and ocular irritation. Less commonly, patients may experience dry eyes, blurred vision, or conjunctival hyperemia. It is important for patients to discuss these potential side effects with their doctor to manage and monitor any adverse reactions effectively.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Ocular Hypertension (OHT) that work by increasing the outflow of aqueous humor. These include prostaglandin analogs such as latanoprost, bimatoprost, and travoprost. These medications help to lower intraocular pressure by enhancing the uveoscleral outflow of aqueous humor. Timolol, a beta-blocker, is also used but works by reducing aqueous humor production rather than increasing outflow. The ongoing study of Travoprost Intraocular Implants aims to provide a sustained release of the drug, potentially offering a more consistent therapeutic effect compared to traditional eye drops.

What other types of research exist?

Promising alternatives to Travoprost Intraocular Implants for ocular hypertension include: 1) Netarsudil, a Rho kinase inhibitor that increases trabecular outflow, 2) Latanoprostene bunod, which combines a prostaglandin analog with nitric oxide to enhance outflow through both the trabecular meshwork and uveoscleral pathways, and 3) Minimally invasive glaucoma surgeries (MIGS) such as the iStent inject and Hydrus Microstent, which improve aqueous humor drainage with fewer complications compared to traditional surgeries.

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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

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

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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:

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I have active inflammation or swelling in my cornea.

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I have a retinal disorder not related to glaucoma.

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

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

0 / 4Eligibility criteria met

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.