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

Glaukos Corporation8 sites in 1 country230 target enrollmentJuly 2012

ConditionsKeratoconus

Interventionsplacebo solution riboflavin solution KXL System

Drugsriboflavin solution placebo solution

Overview

Phase: Phase 3
Intervention: placebo solution
Conditions: Keratoconus
Sponsor: Glaukos Corporation
Enrollment: 230
Locations: 8
Primary Endpoint: Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glaukos Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following criteria in order to be enrolled into the trial:
•Be at least 12 years of age, male or female, of any race;
•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;
•Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
•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);
•Having topographic evidence of keratoconus with a diagnosis of mild, moderate, or severe keratoconus defined as the following:
•Mild Keratoconus:
•Axial topography consistent with keratoconus
•Flat Pentacam keratometry reading ≤ 51.00D
•Moderate Keratoconus:

Exclusion Criteria

•Patients must not meet any of the following criteria in order 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 or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
•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;
•Eyes that have the maximum corneal curvature (Kmax) outside of the central 5mm zone as measured by the Pentacam;