A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Glaukos Corporation
Summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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
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)
- Glaukos Investigative SiteDothan, Alabama
- Glaukos Investigative SiteTeaneck, New Jersey
- Glaukos Investigative SiteWesterville, Ohio