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

February 3, 2026 updated by: Glaukos Corporation

Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • Glaukos Clinical Study Site
        • Contact:
          • Study Manager
          • Phone Number: 949-739-8749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be ≥ 18 and ≤ 55 years of age
  • Diagnosis of keratoconus in the study eye

Exclusion Criteria:

  • Pregnant, lactating or planning a pregnancy
  • Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLK-221 Ophthalmic Solution
GLK-221 Ophthalmic Solution administered topically twice daily to both eyes
Drug: GLK-221 Ophthalmic Solution
GLK-221 Ophthalmic Solution administered twice daily to both eyes
Placebo Comparator: Placebo
Placebo Ophthalmic Solution administered topically twice daily to both eyes
Drug: Placebo Ophthalmic Solution
Placebo Ophthalmic Solution administered twice daily to both eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in maximum corneal curvature
Time Frame: 16 weeks
Mean change from baseline in maximum corneal curvature
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Investigators

  • Study Director: Study Director, MD, Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLK-221-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Keratoconus

Clinical Trials on GLK-221 Ophthalmic Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe