Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

NCT01459679 | Terminated Phase 3 FDA Drug

• 1 other identifier: ACOS-KXL-001
• Study Type: interventional
• Target: 1,721
• Locations: 2 countries
• Sites: 83

Brief Summary

The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.

Conditions

Keratoconus; Corneal Ectasia

Outcome Measures

Primary Outcomes (1)

• Mean change in maximum corneal curvature (Kmax) from baseline

  Month 6 or 12

Secondary Outcomes (1)

• Comparison of treatment groups within each treatment indication

  Month 6 and 12

Study Arms (3)

VibeX Treatment Group A

ACTIVE COMPARATOR

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Device: KXL System (15 mW/cm2); Drug: riboflavin ophthalmic solution

VibeX Treatment Group B

ACTIVE COMPARATOR

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

Device: KXL System (30 mW/cm2); Drug: riboflavin ophthalmic solution

VibeX Treatment Group C

ACTIVE COMPARATOR

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

Device: KXL System (45 mW/cm2); Drug: riboflavin ophthalmic solution

Interventions

KXL System (15 mW/cm2) DEVICE

UVA irradiation for 8 minutes at 15 mW/cm2

VibeX Treatment Group A

KXL System (30 mW/cm2) DEVICE

UVA irradiation for 4 minutes at 30 mW/cm2

VibeX Treatment Group B

KXL System (45 mW/cm2) DEVICE

UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2

VibeX Treatment Group C

riboflavin ophthalmic solution DRUG

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

Also known as: VibeX

VibeX Treatment Group A; VibeX Treatment Group B; VibeX Treatment Group C

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:

• 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 on the day of the fellow eye treatment (which occurs between the 3 to 6 month study eye visits); 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 until one month after the last dose of test article. 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);
• BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;
• Presence of central or inferior steepening on the topographic map;
• 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 topographer taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam;
• Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;
• 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 keratometry reading ≤ 51.00 D on topography map
• Moderate Keratoconus
• Axial topography consistent with keratoconus

You may not qualify if:

• Contraindications, sensitivity or known allergy to 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;
• Corneal pachymetry that is \< 375 microns prior to epithelial debridement at the thinnest point 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:
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
• Clinically significant corneal scarring in the cross-linking treatment zone that is not related to keratoconus or corneal ectasia, in the investigator's opinion, will interfere with the cross-linking procedure;
• A history of delayed epithelial healing in the eye(s) 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;
• Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
• A history of previous corneal crosslinking treatment in the eye to be treated;
• Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device trial within 30 days of the study;
• A history of previous corneal surgery (other than LASIK or PRK for subjects with corneal ectasia) or the insertion of Intacs in the eye(s) to be treated;

Sponsors & Collaborators

• American-European Congress of Ophthalmic Surgery: lead

Study Sites (83)

John Parker

Birmingham, Alabama, 35233, United States

Location

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, 85016, United States

Location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Stanford University School of Medicine

Palo Alto, California, 94303, United States

Location

Grutzmacher, Lewis and Sierra

Sacramento, California, 95815, United States

Location

Center for Sight

Sacramento, California, 95816, United States

Location

Newman Lasik Centers

Sacramento, California, 95821, United States

Location

Batra Vision Medical Group

San Leandro, California, 94578, United States

Location

Delta Eye Medical Group

Stockton, California, 95207, United States

Location

Kaiser Permanente - Kaiser Network Patients in Northern California Only

Walnut Creek, California, 94598, United States

Location

Mile High Corneal Specialists, PC

Denver, Colorado, 80210, United States

Location

Manchester Ophthalmology

Manchester, Connecticut, 06040, United States

Location

Eye Physicians and Surgeons, PC

Milford, Connecticut, 06460, United States

Location

TLC of Miami The Laser Center of Coral Gables

Coral Gables, Florida, 33134, United States

Location

Delray Eye Associates, PA

Delray Beach, Florida, 33484, United States

Location

Braverman Eye Center

Hallandale, Florida, 33009, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Herschel Lasik

Orlando, Florida, 32803, United States

Location

LCA-Vision Inc

Tampa, Florida, 33607, United States

Location

Quantum Vision Centers

Belleville, Illinois, 62226, United States

Location

University of Iowa Hospitals and Clinics

Coralville, Iowa, 52241, United States

Location

Kansas LasikPlus, P.A.

Leawood, Kansas, 66211, United States

Location

Grene Vision Group

Wichita, Kansas, 67208, United States

Location

LaskiPlus Vision Center

Louisville, Kentucky, 40207, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70115, United States

Location

Eyecare Medical Group

Portland, Maine, 04102, United States

Location

GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants

Baltimore, Maryland, 21204, United States

Location

Solomon Eye Physicians and Surgeons

Bowie, Maryland, 20716, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Boston Eye Group

Brookline, Massachusetts, 02446, United States

Location

Ophthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Verdier Eye Center P.L.C.

Grand Rapids, Michigan, 49546, United States

Location

Michigan Cornea Consultants

Southfield, Michigan, 48034, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Eye Surgery and Laser Center

Madison, Mississippi, 39110, United States

Location

Pepose Vision Institute/ Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Ophthamology Consultants LLC

St Louis, Missouri, 63131, United States

Location

The Eye Clinic Surgicenter

Billings, Montana, 59102, United States

Location

Eye Surgical Associates

Lincoln, Nebraska, 68506, United States

Location

Kugler Vision, PC

Omaha, Nebraska, 68144, United States

Location

Wellish Vision Institute

Las Vegas, Nevada, 89119, United States

Location

Princeton Eye Group

Princeton, New Jersey, 08540, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

CNY Eye Care

De Witt, New York, 13214, United States

Location

North Shore LIJ Health Systems

Great Neck, New York, 11021, United States

Location

Ramapo Ophthalmology Associates, LLP

Pomona, New York, 10970, United States

Location

Carolina Vision Center

Fayetteville, North Carolina, 28304, United States

Location

Bagan Strinden Vision

Fargo, North Dakota, 58103, United States

Location

Comprehensive Eye Care of Central Ohio

Westerville, Ohio, 43082, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Casey Eye Institute/OHSU

Portland, Oregon, 97239, United States

Location

Ophthalmic Partners of PA, P.C.

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Schein Ernst Eye Associates

Harrisburg, Pennsylvania, 17110, United States

Location

Scheie Eye Institute, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Corneal Associates, Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Northeastern Eye Institute

Scranton, Pennsylvania, 18503, United States

Location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Wright Vision Center

Rapid City, South Dakota, 57701, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Loden Vision Center

Goodlettsville, Tennessee, 37072, United States

Location

Wang Vision Institute

Nashville, Tennessee, 37203, United States

Location

Dell Laser Consultants

Austin, Texas, 78746, United States

Location

Buena Vista Eyecare

El Paso, Texas, 79902, United States

Location

Eye Consultants of Texas

Grapevine, Texas, 76051, United States

Location

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

Slade and Baker Vision Center

Houston, Texas, 77027, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

Hoopes Vision

Draper, Utah, 84020, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

University of Utah Dept. of Ophthalmology & Visual Sciences

Salt Lake City, Utah, 84132, United States

Location

Silk Vision & Surgical Center

Annandale, Virginia, 22003, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Commonwealth Eye Associates

Richmond, Virginia, 23238, United States

Location

Eye Care Center of Virginia

Richmond, Virginia, 23294, United States

Location

Beach Eye Care

Virginia Beach, Virginia, 23454, United States

Location

Evergreen Eye Center

Federal Way, Washington, 98003, United States

Location

Gundersen Clinic, Ltd.

La Crosse, Wisconsin, 54601, United States

Location

Dean Foundation for Health, Research and Education, Inc.

Madison, Wisconsin, 43715, United States

Location

Lilia Rivera

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• John Vukich, MD

  American-European Congress of Ophthalmic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: October 26, 2011
• Study Start: July 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 5, 2018

Record last verified: 2018-06

Locations

PR (1); US (82)