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

Part of paid clinical trials in Westerville, Ohio.

Sponsor
Glaukos Corporation
Study ID
NCT07400952
Phase
PHASE2
Status
Recruiting
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Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • GLK-221 Ophthalmic Solution — DRUG
    GLK-221 Ophthalmic Solution administered twice daily to both eyes
  • Placebo Ophthalmic Solution — DRUG
    Placebo Ophthalmic Solution administered twice daily to both eyes

Study Details

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.

Key Dates

Start date
Dec 23, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Glaukos Clinical Study SiteWestervilleOhio43082
Study Manager
949-739-8749

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Glaukos Clinical Study Site· Westerville, OH

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