Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

NCT01643226 | Completed Phase 3

• 1 other identifier: KXL-002
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 8

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

Keratoconus

Outcome Measures

Primary Outcomes (1)

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

  baseline to 6 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)

riboflavin solution and KXL System

EXPERIMENTAL

Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by UVA irradiation for 4 minutes

Drug: riboflavin solution; Device: KXL System

placebo solution and KXL System

PLACEBO COMPARATOR

Subjects will receive 0.0% riboflavin ophthalmic solution (Placebo) followed by UVA Irradiation for 4 minutes

Drug: placebo solution; Device: KXL System

Interventions

riboflavin solution DRUG

0.12% riboflavin ophthalmic solution

Also known as: VibeX

riboflavin solution and KXL System

placebo solution DRUG

0.0% riboflavin ophthalmic solution

Also known as: placebo

placebo solution and KXL System

KXL System DEVICE

30 mW/cm2

Also known as: UVA Irradiation

placebo solution and KXL System; riboflavin solution and KXL System

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 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:
• Axial topography consistent with keratoconus
• Flat Pentacam keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00 D
• Severe Keratoconus:
• Axial topography consistent with keratoconus with marked areas of steepening
• Flat Pentacam keratometry reading ≥ 56.01 D

You may not qualify if:

• 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;
• 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 keratoconus 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;

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (8)

Gordon -Weiss Vision Institute

San Diego, California, 92122, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Cornea & Laser Eye Institute; Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

Columbia University Harkness Eye Institute

New York, New York, 10032, United States

Location

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

See Clearly Vision

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

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
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)