Patients must not meet any of the following criteria in order to be enrolled into the trial:
1. Contraindications, sensitivity or known allergy to the test article(s) or their components;
2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the treatment of either eye or during the course of the study;
3. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated;
4. Eyes which are aphakic;
5. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
6. Eyes that have the maximum corneal curvature (Kmax), as identified and measured by topography, outside of the central 5mm zone;
7. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
b. Clinically significant corneal scarring in the cross-linking treatment zone that is not related to keratoconus or corneal ectasia, in the investigator’s opinion, will interfere with the cross-linking procedure;
8. A history of delayed epithelial healing in the eye(s) to be treated;
9. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
10. Patients with a current condition that, in the investigator’s opinion, would interfere with or prolong epithelial healing;
11. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
12. A history of previous corneal crosslinking treatment in the eye to be treated;
13. Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device trial within 30 days of the study;
14. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated.
15. In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
Patients must not meet any of the following criteria in order to be enrolled into the keratoconus arm of the trial:
16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
17. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.