iStent Infinite vs. Competitor Device for Glaucoma

Overseen By Khan Lau, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaukos Corporation

Disqualifiers: Traumatic glaucoma, Angle closure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

179 Participants Needed

Trial Summary

What is the purpose of this trial?

A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor

Eligibility Criteria

This trial is for people with specific types of glaucoma: Primary Open-Angle Glaucoma, Secondary Pseudoexfoliative Glacoma, or Secondary Pigmentary Glaucoma. It's not suitable for those with other forms like traumatic, uveitic, neovascular glaucoma, angle closure glaucoma, and any linked to vascular disorders.

Inclusion Criteria

I have been diagnosed with a specific type of glaucoma.

Exclusion Criteria

I have a type of glaucoma other than open-angle.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with either the iStent Infinite system or a competitor device

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Competitor Device
• iStent Infinite
• Ivantis Hydrus

Trial Overview The study compares the iStent Infinite device against a competitor's product in treating open-angle glaucoma. Participants will receive one of these devices to see which is more effective.

Participant Groups

Group I: iStent Infinite Active Control 1 Intervention

Subjects implanted with iStent Infinite system

Group II: Competitor Device Active Control 1 Intervention

Subject implanted with competitor device

iStent Infinite is already approved in United States for the following indications:

Approved in United States as iStent infinite for:

• Primary open-angle glaucoma in adult patients who have failed previous medical and surgical treatment

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School