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

Glaukos

Status and phase: Enrolling; Phase 2

Conditions: Keratoconus

Treatments: Drug: Placebo Ophthalmic Solution; Drug: GLK-221 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT07400952

GLK-221-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

GLK-221 Ophthalmic Solution

Experimental group

Description:

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

Treatment:

Drug: GLK-221 Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

Placebo Ophthalmic Solution administered topically twice daily to both eyes

Treatment:

Drug: Placebo Ophthalmic Solution