Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

Inclusion Criteria (all subjects):

1. Be at least 12 years of age, male or female, of any race;

2. Provide written informed consent and sign a HIPAA form. Patients who are under the age
of 18 will need to sign an assent form as well as having a parent or legal guardian
sign an informed consent;

3. Willingness and ability to follow all instructions and comply with schedule for
follow-up visits;

4. For females capable of becoming pregnant, agree to have urine pregnancy testing
performed prior to randomization of the study eye and on the day of the fellow eye
treatment (which occurs between the 3 to 6 month study eye visits); must not be
lactating, and must agree to use a medically acceptable form of birth control for at
least one week prior to the randomization visit and continue to use the method until
one month after the last dose of test article. Acceptable forms for birth control are
spermicide with barrier, oral contraceptive, injectable or implantable method of
contraception, transdermal contraceptive, intrauterine device, or surgical
sterilization of partner. For non-sexually active females, abstinence will be
considered an acceptable form of birth control. Women considered capable of becoming
pregnant include all females who have experienced menarche and have not experienced
menopause (as defined by amenorrhea for greater than 12 consecutive months) or have
not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy);

5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;

6. Presence of central or inferior steepening on the topographic map;

7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period
prior to the screening visit(s);

8. Contact Lens Wearers Only: manifest refraction must be stable between two visits which
occur at least 7 days apart. A stable refraction is one in which the manifest
refraction spherical equivalent and the average K (Km) on the topographer taken at the
first visit do not differ by more than 0.75 D from the respective measurements taken
at the second exam;

Inclusion Criteria (keratoconus subjects only):

9. Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;

10. Having topographic evidence of keratoconus with a diagnosis of mild, moderate or
severe keratoconus defined as the following:

- Mild Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≤ 51.00 D on topography map

- Moderate Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on
topography map

- Severe Keratoconus:

1. Axial topography consistent with keratoconus with marked areas of steepening

2. Flat keratometry reading ≥ 56.01 D on topography map

Inclusion Criteria (corneal ectasia subjects only):

11. Having a diagnosis of corneal ectasia after refractive surgery;

12. Having axial topography consistent with ectasia;

Exclusion Criteria (all subjects):

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 randomization or 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. Previous ocular condition (other than refractive error) in the eye to be treated that
may predispose the eye for future complications. For example:

1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis,
recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)

2. 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;

7. A history of delayed epithelial healing in the eye(s) to be treated;

8. Patients with nystagmus or any other condition that would prevent a steady gaze during
the treatment or other diagnostic tests;

9. Patients with a current condition that, in the investigator's opinion, would interfere
with or prolong epithelial healing;

10. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking
treatment.

11. A history of previous corneal crosslinking treatment in the eye to be treated;

12. 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;

13. A history of previous corneal surgery (other than LASIK or PRK for subjects with
corneal ectasia) or the insertion of Intacs in the eye(s) to be treated;

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;

Exclusion Criteria (Keratoconus subjects only):

16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the
severity grading scheme.