RecruitingPhase 1Phase 2NCT05314738
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Sponsor
Glaukos Corporation
Enrollment
150 participants
Start Date
Mar 8, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Eligibility
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria4
- 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 Criteria3
- 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
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Interventions
COMBINATION_PRODUCTNXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
COMBINATION_PRODUCTNXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
COMBINATION_PRODUCTNXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
COMBINATION_PRODUCTSham Treatment
Sham Drops and No exposure to NXL system
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05314738