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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07400952
Enrollment
100
Registered
2026-02-10
Start date
2025-12-23
Completion date
2027-04-01
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus

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.

Interventions

DRUGGLK-221 Ophthalmic Solution

GLK-221 Ophthalmic Solution administered twice daily to both eyes

DRUGPlacebo Ophthalmic Solution

Placebo Ophthalmic Solution administered twice daily to both eyes

Sponsors

Glaukos Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline in maximum corneal curvature16 weeksMean change from baseline in maximum corneal curvature

Countries

United States

Contacts

CONTACTStudy Manager
ClinicalResearch@Glaukos.com949-739-8749
STUDY_DIRECTORStudy Director, MD

Glaukos Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026