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Recruiting NCT07400952

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

Phase II Interventional Keratoconus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GLK-221 Ophthalmic Solution, Placebo Ophthalmic Solution.
Who it may be relevant to
Registry conditions: Keratoconus. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Glaukos Clinical Study Site — Westerville

Identifiers

NCT: NCT07400952 · GLK-221-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗