GLK-221 eye drops for keratoconus
Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Westerville, Ohio) |
| Trial ID | NCT07400952 on ClinicalTrials.gov |
What this trial studies
This is a phase 2, randomized, parallel-group, placebo-controlled trial testing twice-daily topical GLK-221 versus matching placebo in adults with keratoconus. Participants are adults aged 18 to 55 with a diagnosis of keratoconus in the study eye and will be followed for safety and efficacy outcomes. The trial is run by Glaukos at clinical sites and uses standard ophthalmic assessments such as corneal shape and visual function measures to gauge effect. Safety monitoring will track ocular and systemic adverse events throughout the treatment period.
Who should consider this trial
Good fit: Adults 18–55 with a documented diagnosis of keratoconus in the study eye who are willing to attend study visits and are not pregnant or lactating are the intended participants.
Not a fit: People who are pregnant, breastfeeding, planning a pregnancy, or recently enrolled in another investigational drug or device trial are excluded and may not receive benefit from participation.
Why it matters
Potential benefit: If successful, GLK-221 eye drops might improve or stabilize corneal shape and vision, offering a non-surgical treatment option for keratoconus.
How similar studies have performed: Topical pharmacologic treatments for keratoconus are relatively novel, whereas surgical approaches like corneal cross-linking have established benefit and topical therapies have shown limited prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Westerville, Ohio
- Glaukos Clinical Study Site — Westerville, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Study Manager
- Email: ClinicalResearch@Glaukos.com
- Phone: 949-739-8749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.