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Recruiting

NCT Number: NCT07400952

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

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.

Recruiting

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glaukos Clinical Study Site

Westerville, Ohio, 43082, United States

Location status: Recruiting

Location contact

Study Manager

CONTACT

949-739-8749

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Mean change from baseline in maximum corneal curvature

    Time frame: 16 weeks

    Mean change from baseline in maximum corneal curvature

Study contacts

Contact information is provided by the study sponsor or research team.

Study Manager

CONTACT

[email protected]

949-739-8749

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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