What side effects are associated with this type of intervention?

Common treatments for Open-Angle Glaucoma, such as prostaglandin analogs (e.g., Travoprost), often cause side effects including eye redness, eyelash growth, and changes in iris pigmentation. Beta-blockers can lead to systemic effects like bradycardia, hypotension, and respiratory issues. Alpha agonists may cause allergic reactions, dry mouth, and fatigue. Carbonic anhydrase inhibitors can result in a metallic taste, frequent urination, and tingling in the fingers and toes. Patients should discuss these potential side effects with their doctor to determine the most suitable treatment.

What prior FDA approvals exist?

FDA-approved treatments for Open-Angle Glaucoma that increase the outflow of aqueous humor include prostaglandin analogs such as latanoprost, bimatoprost, and travoprost. These medications work by enhancing the uveoscleral outflow, thereby reducing intraocular pressure. Travoprost, in particular, is similar to the Travoprost Intraocular Implant being studied, as it also aims to lower intraocular pressure by increasing aqueous humor outflow.

What other types of research exist?

Promising novel alternatives to the Travoprost Intraocular Implant for Open-Angle Glaucoma include sustained-release prostaglandin analogues and nanotechnological-release delivery systems. These approaches aim to improve adherence and efficacy by providing consistent drug delivery and reducing the need for daily topical eye drops.

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Device

Travoprost Implant + iStent vs. iStent Alone for Glaucoma

Phase 3

Recruiting

Research Sponsored by Glaukos Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of open-angle glaucoma or ocular hypertension

Be older than 18 years old

Must not have

Unmedicated (washed out) IOP of >36 mmHg in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Pivotal Trial

Summary

This trial involves adults with high eye pressure who have an iStent. They will receive either a travoprost implant, which releases medication to lower eye pressure, or a non-medicated procedure. The study will follow them for about a year.

Who is the study for?

This trial is for adults with open-angle glaucoma or ocular hypertension who have had the iStent infinite system placed in their eye. They must not have an unmedicated eye pressure over 36 mmHg, be allergic to travoprost, have a high cup/disc ratio, poor vision worse than 20/80, or any other risky eye conditions.

What is being tested?

The study tests if adding a travoprost intraocular implant after placing the iStent infinite device helps lower eye pressure better than the stent alone. Participants are randomly chosen to get either the real implant or a pretend procedure and will be monitored for one year.

What are the potential side effects?

Possible side effects of the travoprost implant may include redness, discomfort in the eye, blurry vision, dry eyes or eyelash growth. The sham procedure might cause similar symptoms due to placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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...

My eye pressure is over 36 mmHg without medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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 mean diurnal intraocular pressure (IOP)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: iDose TRExperimental Treatment2 Interventions

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Group II: sham procedurePlacebo Group2 Interventions

Sham surgical procedure in subjects who had successful iStent infinite placement

0 / 2Eligibility 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 Open-Angle Glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Medications like prostaglandin analogs (e.g., Travoprost) increase the outflow of aqueous humor through the uveoscleral pathway, effectively lowering IOP. Beta-blockers and carbonic anhydrase inhibitors reduce the production of aqueous humor, thereby decreasing IOP. Alpha agonists can both decrease aqueous humor production and increase its outflow. These mechanisms are crucial for Open-Angle Glaucoma patients as they help manage the disease by maintaining lower IOP, thus reducing the risk of progressive vision loss.

The effect of topical PGF2 alpha on uveoscleral outflow and outflow facility in the rabbit eye.