To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.
Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change in Kmax from baseline to Month 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
201
Riboflavin Ophthalmic Solution A
Riboflavin Ophthalmic Solution B
Placebo Vehicle of Test Article
Ophthalmic Consultants of Boston
Waltham, Massachusetts, United States
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Time frame: 6 months
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax
Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mock UVA light source
Cross-linking UVA light source