Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 55

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment100 (estimated)
SponsorGlaukos Corporation
Industry-sponsored
Locations1 site (Westerville, Ohio)
StatusRecruiting
StartedDecember 23, 2025
Main results expectedApril 2027
Study endsApril 2027
Registry record updatedFebruary 10, 2026
Trial IDNCT07400952 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.