A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus
Overview
- Phase
- Phase 3
- Intervention
- riboflavin solution
- Conditions
- Keratoconus
- Sponsor
- Glaukos Corporation
- Enrollment
- 92
- Locations
- 11
- Primary Endpoint
- Change in Kmax from baseline
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria in order to be enrolled in the trial:
- •Be at least 12 years of age, male or female, of any race;
- •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;
- •Willingness and ability to follow all instructions and comply with schedule for follow-up visits, including the ability to read English to complete the NEI-VFQ 25 questionnaire;
- •For females capable of becoming pregnant, agree to have urine pregnancy testing performed at Visit 2 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 Visit 2, 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);
- •Subjects \> 25 years old at the time of screening of their study eye must meet the following criteria. Subjects ≤ 25 years old and all subjects who have their fellow-eye or crossover eye treated are not required to meet these criteria;
- •Having a diagnosis of progressive keratoconus defined as one or more of the following changes over a period of 36 months or less:
- •An increase of ≥ 1.00 D in the steepest keratometry value (ksteep)
- •An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction or as evaluated by comparing eyeglass or contact lens prescriptions to current subjective manifest refraction
- •A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D in subjective manifest refraction or as evaluated by comparing eyeglass or contact lens prescriptions to current subjective manifest refraction
Exclusion Criteria
- •Subjects must not meet any of the following criteria to be enrolled in the trial:
- •Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
- •If female, be pregnant, nursing or planning a pregnancy during the course of the study or have a positive urine pregnancy test at Visit 2 prior to randomization or treatment of either eye;
- •Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
- •A history of previous corneal surgery or the insertion of Intacs in the eye to be treated;
- •A history of previous Limbal Relaxing Incision (LRI) procedure in the eye to be treated;
- •Corneal pachymetry that is \< 375 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the 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 that may predispose the eye for future complications. For example:
Arms & Interventions
riboflavin solution and KXL System
The cornea will receive 5 drops of VibeX (0.12% riboflavin ophthalmic solution). Five additional VibeX drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Intervention: riboflavin solution
riboflavin solution and KXL System
The cornea will receive 5 drops of VibeX (0.12% riboflavin ophthalmic solution). Five additional VibeX drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Intervention: KXL System
placebo solution and KXL System
The cornea will receive 5 drops of placebo (0.0% riboflavin ophthalmic solution. Five additional placebo drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Intervention: placebo solution
placebo solution and KXL System
The cornea will receive 5 drops of placebo (0.0% riboflavin ophthalmic solution. Five additional placebo drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Intervention: KXL System
Outcomes
Primary Outcomes
Change in Kmax from baseline
Time Frame: 12 months
The primary endpoint is the mean change from baseline to 12 months in maximum corneal curvature (Kmax) between the VibeX treatment group and the Placebo control group.