Progressive Keratoconus Clinical Trial
Official title:
A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Verified date | July 2023 |
Source | Glaukos Corporation |
Contact | Marco Armijo |
Phone | 562-761-7965 |
marmijo[@]glaukos.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | August 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Provide written informed consent - Ability to hold gaze sufficiently stable for study testing - Willingness and ability to follow all instructions and comply with schedule for follow-up visits - Have a diagnosis of keratoconus Exclusion Criteria: - Known allergy or sensitivity to the test articles or components - Any disease causing abnormal topography other than keratoconus - Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications |
Country | Name | City | State |
---|---|---|---|
United States | Glaukos Investigative Site | Dothan | Alabama |
United States | Glaukos Investigative Site | Teaneck | New Jersey |
United States | Glaukos Investigative Site | Westerville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Topography | Change in Kmax topography value from baseline | 12 Months | |
Secondary | Distance Uncorrected Visual Acuity (UCVA) | Change in Distance UCVA | 12 Months |
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