Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Condition: Progressive Keratoconus
MeSH terms: Keratoconus
Intervention: Test Article A; Test Article B; Placebo; KXL medical device system; KXL medical device system
Intervention description: Riboflavin Ophthalmic Solution A; Riboflavin Ophthalmic Solution B; Placebo Vehicle of Test Article; Mock UVA light source; Cross-linking UVA light source
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in
      impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with
      progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to
      penetrate the cornea without the need to remove the epithelium, the outer most layer of the
      cornea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be between 12 and 55 years of age, male or female, of any race;

          2. Provide written informed consent and sign a HIPAA form. Subjects who are under the age
             of 18 (or have not yet reached the age of majority per local regulations) will need to
             sign an assent form as well as having a parent or legal guardian sign an informed
             consent

          3. Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire;

          4. Willingness and ability to follow all instructions and comply with schedule for
             follow-up visits;

          5. For females capable of becoming pregnant, agree to have urine pregnancy testing
             performed prior to randomization of each study 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, and continue to use the method for one month following the
             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);

          6. Having topographic and clinical evidence of keratoconus

        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. Previous ocular condition (other than refractive error) in the eye to be treated that
             may predispose the eye for future complications.

          4. A history of delayed epithelial healing in the eye to be treated or a current
             condition that may interfere with or prolong epithelial healing;

          5. A history of previous corneal cross-linking treatment in the eye to be treated;

          6. Have used an investigational drug or device within 30 days of screening or be
             concurrently enrolled in another investigational drug or device trial within 30 days
             of the study.