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

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

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.

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