GLK-221 Ophthalmic Solution for Keratoconus

Overseen By Study Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Glaukos Corporation

Disqualifiers: Pregnancy, Other trial participation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus.

Who Is on the Research Team?

Study Director, MD

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 55 with keratoconus, a condition that affects the shape of the cornea in the eye. Participants must have this diagnosis in at least one eye.

Inclusion Criteria

I am between 18 and 55 years old.

I have been diagnosed with keratoconus in one eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLK-221 or placebo ophthalmic solution administered topically twice daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GLK-221 Ophthalmic Solution

Trial Overview

The study tests GLK-221 Ophthalmic Solution against a placebo solution when used twice daily. It aims to see if GLK-221 is safe and works better than a placebo for people with keratoconus.

How Is the Trial Designed?

Group I: GLK-221 Ophthalmic Solution Experimental Treatment 1 Intervention

GLK-221 Ophthalmic Solution administered topically twice daily to both eyes

Group II: Placebo Placebo Group 1 Intervention

Placebo Ophthalmic Solution administered topically twice daily to both eyes

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