100 Participants Needed

GLK-221 Ophthalmic Solution for Keratoconus

SM
Overseen ByStudy Manager
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Glaukos Corporation
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop solution called GLK-221 to determine its effectiveness for keratoconus, a condition where the cornea becomes thin and cone-shaped. Researchers aim to assess the safety and efficacy of the eye drops when used twice daily. Participants will receive either the GLK-221 solution or a placebo (a look-alike solution with no active medicine) for comparison. This trial suits adults diagnosed with keratoconus in at least one eye. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GLK-221 Ophthalmic Solution is likely to be safe for humans?

Research shows that GLK-221 Eye Drops are generally well-tolerated. In earlier studies, most people using similar eye treatments experienced mild side effects that often resolved on their own within a month. Only a small number (1-2%) had longer-lasting issues, which remained quite rare. This treatment is now in a Phase 2 trial, indicating that earlier research found it safe enough for further testing. Overall, while side effects can occur, they appear manageable and not severe for most people.12345

Why do researchers think this study treatment might be promising for keratoconus?

Unlike the standard treatments for keratoconus, which often involve rigid contact lenses or surgical procedures like corneal cross-linking, GLK-221 Ophthalmic Solution offers a non-invasive approach. This experimental eye drop is applied topically twice daily, providing a convenient and potentially safer alternative to surgery. Researchers are excited about GLK-221 because it may work by strengthening the cornea through a novel mechanism that could stabilize the condition and improve vision without the need for more invasive interventions.

What evidence suggests that GLK-221 Ophthalmic Solution might be an effective treatment for keratoconus?

Research shows that GLK-221 Eye Drops, which participants in this trial may receive, might help treat keratoconus. This condition causes the cornea, the clear front part of the eye, to thin and bulge, affecting vision. Early studies found that people using GLK-221 experienced better results than those using a placebo, a substance with no active ingredients. The drops are applied directly to the eyes and aim to stabilize or improve vision by strengthening the cornea. Initial findings suggest this treatment might be more effective than current options, but further research is needed to confirm these results.12367

Who Is on the Research Team?

SD

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?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: GLK-221 Ophthalmic SolutionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

NCT07400952 | Placebo-controlled Study to Evaluate the ...

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

GLK-221 Ophthalmic Solution for Keratoconus

It aims to see if GLK-221 is safe and works better than a placebo for people with keratoconus.

Placebo-controlled Study to Evaluate the Safety and Efficacy ...

Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus. Glaukos logo.

Top Keratoconus Clinical Trials | Power

GLK-221 Ophthalmic Solution for Keratoconus​​ Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28503442/

Clinical outcomes at one year following keratoconus ...

This study evaluated the clinical outcomes in keratoconus corneas following accelerated transepithelial corneal collagen cross-linking (CXL) (Avedro KXL ...

203324Orig1s000 | FDA

There are non-comparative data from a total of 293 progressive keratoconus eyes exposed to CXL (including CXL treated patients, sham patients treated with ...

Clinical Data on iLink® | Corneal Health

The majority of adverse events reported resolved during the first month. In 1-2% of patients, AEs continued to be reported at 12 months, including corneal ...