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

Glaukos Corporation

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.

Eligibility

Age range: 18–55 years
Sex: All
Healthy volunteers: No

Detailed 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

Interventions

Drug
GLK-221 Ophthalmic Solution
GLK-221 Ophthalmic Solution administered twice daily to both eyes
Drug
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution administered twice daily to both eyes

Location

Glaukos Clinical Study Site
Westerville, Ohio
949-739-8749