Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Phase 1
Recruiting
- Conditions
- Progressive Keratoconus
- Registration Number
- NCT05314738
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
- Detailed Description
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Topography 12 Months Change in Kmax topography value from baseline
- Secondary Outcome Measures
Name Time Method Distance Uncorrected Visual Acuity (UCVA) 12 Months Change in Distance UCVA
Trial Locations
- Locations (1)
Glaukos Investigative Site
🇺🇸Westerville, Ohio, United States
Glaukos Investigative Site🇺🇸Westerville, Ohio, United States