GLK-221 eye drops for keratoconus
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
Run by Glaukos Corporation · NCT07400952 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Westerville, Ohio) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07400952 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Glaukos Clinical Study Site
Westerville, Ohio, United States Recruiting
Study contacts
- Study coordinator: Study Manager
- Email: ClinicalResearch@Glaukos.com
- Phone: 949-739-8749
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia
This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.
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Brillouin hydration mapping to study cornea health
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Same-day bilateral corneal cross-linking for keratoconus
This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.
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A Smart Aperture Lens to Help Keratoconus and Presbyopia
This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.
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Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus
This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.
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Epi-ON corneal crosslinking with UVA for people with Down syndrome and corneal ectasia
This trial will try Epi-ON corneal crosslinking (riboflavin drops plus UVA light) to see if it can slow or stop corneal thinning and vision loss in people with Down syndrome who have keratoconus or similar ectatic corneal conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.