Recruiting
Phase 2

GLK-221

Sponsor:

Glaukos Corporation

Code:

NCT07400952

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

GLK-221 Ophthalmic Solution

Placebo Ophthalmic Solution

Study Details

Brief summary:

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.

Conditions

Keratoconus

Study ID

NCT07400952

Start date

Dec 23, 2025

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GLK-221 Ophthalmic Solution

GLK-221 Ophthalmic Solution administered topically twice daily to both eyes

placebo comparator: Placebo

Placebo Ophthalmic Solution administered topically twice daily to both eyes

Interventions

GLK-221 Ophthalmic Solution

GLK-221 Ophthalmic Solution administered twice daily to both eyes

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution administered twice daily to both eyes

Primary outcome measure

  • Mean change from baseline in maximum corneal curvature [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Study Manager

949-739-8749ClinicalResearch@Glaukos.com

Locations

Glaukos Clinical Study Site

Recruiting

Westerville, Ohio, United States, 43082

Contacts

Study Manager

949-739-8749

More Information

Sponsor

Glaukos Corporation

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Keratoconus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-02-10.