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

NCT01643252 | Withdrawn Phase 3

• 1 other identifier: KXL-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Corneal Ectasia

Keywords

Corneal Ectasia; Refractive surgery; Cross-Linking

Outcome Measures

Primary Outcomes (2)

• Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group

  Baseline to 6 months

• Safety

  The primary safety endpoints are loss of BSCVA beginning at the 6 month follow-up examination, specifically, the percentage of eyes that have a loss of 15 or more letters in BSCVA on the ETDRS chart as compared to baseline and the incidence of serious ophthalmic adverse events.

  12 months

Secondary Outcomes (1)

• Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group

  Baseline to 12 months

Study Arms (2)

Placebo and UVA light exposure

PLACEBO COMPARATOR

Drug: placebo: 0.0% riboflavin ophthalmic solution with the KXL system

Riboflavin drops and UVA light exposure

ACTIVE COMPARATOR

Drug: riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system

Interventions

riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system DRUG

Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes

Riboflavin drops and UVA light exposure

placebo: 0.0% riboflavin ophthalmic solution with the KXL system DRUG

Subjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes

Placebo and UVA light exposure

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a diagnosis of corneal ectasia after refractive surgery;
• Having axial topography consistent with corneal ectasia;
• Presence of central or inferior steepening on the Pentacam map;
• BSCVA (Best Spectacle Corrected Visual Acuity) of ≥ 1 letter and ≤ 80 letters on ETDRS (Early Treatment of Diabetic Retinopathy Study) chart;
• Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);
• 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.

You may not qualify if:

• Patients must not meet any of the following criteria in order to be enrolled into 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;
• A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
• A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) 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;
• Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.);
• 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;
• A history of delayed epithelial healing in the eye to be treated;
• Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
• Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;

Sponsors & Collaborators

• Glaukos Corporation: lead

MeSH Terms

Interventions

Riboflavin

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Vineeta Belanger

  Glaukos Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Last Updated: April 26, 2021

Record last verified: 2021-04