Status:
RECRUITING
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Lead Sponsor:
Glaukos Corporation
Conditions:
Progressive Keratoconus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05314738
Start Date
March 8 2022
End Date
February 1 2026
Last Update
July 8 2024
Active Locations (3)
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1
Glaukos Investigative Site
Dothan, Alabama, United States, 36301
2
Glaukos Investigative Site
Teaneck, New Jersey, United States, 07666
3
Glaukos Investigative Site
Westerville, Ohio, United States, 43082