Corneal Sensitivity Cross-linking Keratoconus

Inclusion Criteria:

• Be at least 18 years of age

• Provide written consent and sign a HIPAA form

• Willingness and ability to follow all instructions and comply with schedule forfollow-up visits

• For females capable of becoming pregnant,agreet o have uurine pregnancy testingperformed prior to treatment; must not be lactating, and must agree to use a medicallyacceptable form of birth control for at least one week prior to the treatment andcontinue to use the method until 1 month after the last dose of investigationalproduct.

• Having topographic evidence of keratoconus which is graded as lower stage progressivekeratoconus

• Presence of central or inferior steepening on the Pentacam map

• Steepest keratometry (Kmax) value greater than or equal to 51.00D

• BSCVA of 80 letters or fewer for keratoconus on ETDRS chart

• Contact lens wearers only: remove contact lenses one week prior to the screeningrefraction

• Contact lens wearers only: manifest refraction must be stable between two visits thatoccur at least 7 days apart

Exclusion Criteria:

• Contraindications, sensitivity or known allergy to the use of the test articles(S) ortheir components

• If female, be pregnant, nursing, or planning a pregnancy or have a positive urinepregnancy test at Visit 2 prior to treatment or during the course of the study

• Eyes classified as either normal,atypical normal,keratoconus suspect or mildkeratoconus on the severity grading scheme

• A history of the insertion of INTACS in the eye to be treated

• A history of previous limbal relaxing incision procedure in the eye to be treated

• Corneal pachymetry that is <350 microns at the thinnest point measured by Pentacam inthe eye to be treated

• Eyes which are aphakic

• Eyes which are pseudophakic and do not have a UV blocking lens implanted

• Previous ocular condition (other than refractive error) in the eye to be treated thatmay predispose the eye for future complications.

• A history of delayed epithelial healing in the eye to be treated

• Patients with nystagmus or any other condition that would prevent a steady gaze duringthe treatment or other diagnostic tests

• Patients with a currnet condition that, in the investigator's opinion,would interferewith or prolong epithelial healing

• Taking Vitamin C (ascorbic acid) supplements within 1 week of the crosslinkingtreatment

• A history of previous corneal crosslinking treatment in the eye to be treated

• Have used an investigational drug or device within 30 days of the study or beconcurrently enrolled in another investigational drug or device study within 30 daysof the study