Safety and Efficacy Study for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

The objectives of this study are to evaluate the safety and efficacy of corneal collagen
cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as
compared to placebo in impeding the progression of, and/or reducing, maximum corneal
curvature.

Inclusion Criteria

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 prior to treatment of a
fellow and/or cross-over eye; 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, one week prior to treatment of a fellow eye or cross-over eye,
and continue to use the method for one month following the last treatment. 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. Having a diagnosis of corneal ectasia after refractive surgery;

6. Having axial topography consistent with corneal ectasia;

7. Presence of central or inferior steepening on the Pentacam map;

8. BSCVA (Best Spectacle Corrected Visual Acuity) of 80 letters or fewer on ETDRS (Early
Treatment of Diabetic Retinopathy Study) chart;

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

10. 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 Pentacam taken at the
first visit do not differ by more than 0.75 D from the respective measurements taken
at the second exam.

Exclusion Criteria

1. Contraindications, sensitivity or known allergy to the use of 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. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be
treated.

4. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be
treated;

5. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the
thinnest point measured by Pentacam in the eye to be treated;

6. Eyes which are aphakic;

7. Eyes which are pseudophakic and do not have a UV blocking lens implanted;

8. Eyes that have the maximum corneal curvature (Kmax) outside of the central 5mm zone
as measured by the Pentacam;

9. 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,
corneal melt, corneal dystrophy, etc.);

2. Clinically significant corneal scarring in the cross-linking treatment zone that
is not related to corneal ectasia or, in the investigator's opinion, will
interfere with the cross-linking procedure;

10. A history of delayed epithelial healing in the eye to be treated;

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

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

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

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

15. 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;

16. In addition, the Investigator may exclude or discontinue any subject for any sound
medical reason.