What side effects are associated with this type of intervention?

Prostaglandin analogs, such as travoprost, are commonly used to treat ocular hypertension by increasing aqueous humor outflow. Known side effects include conjunctival hyperemia (eye redness), eyelash growth, and changes in iris pigmentation. Some patients may experience ocular irritation, dry eyes, or blurred vision. Less commonly, these medications can cause macular edema or exacerbate pre-existing ocular conditions. Regular follow-up with an ophthalmologist is recommended to monitor for these side effects.

What prior FDA approvals exist?

The FDA has approved several prostaglandin analogs for the treatment of ocular hypertension, which work by increasing the outflow of aqueous humor. These include latanoprost (Xalatan), bimatoprost (Lumigan), and travoprost (Travatan). These medications are effective in reducing intraocular pressure and are commonly used as first-line treatments for ocular hypertension and open-angle glaucoma.

What other types of research exist?

Promising novel alternatives to Travoprost Intraocular Implants for ocular hypertension patients include: 1) Rho kinase inhibitors (e.g., Netarsudil) which increase aqueous humor outflow through the trabecular meshwork, 2) Nitric oxide-donating prostaglandin analogs (e.g., Latanoprostene bunod) which enhance both trabecular and uveoscleral outflow, and 3) Minimally invasive glaucoma surgeries (MIGS) such as the iStent or Hydrus Microstent, which improve aqueous humor drainage.

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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

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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.

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 that is 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

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.