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A Multi-Center, Randomized, 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 or Corneal Ectasia After Refractive Surgery

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
American-European Congress of Ophthalmic Surgery
ClinicalTrials.gov Identifier:
NCT01459679
First received: September 19, 2011
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Keratoconus
Corneal Ectasia
Device: KXL System (15 mW/cm2)
Device: KXL System (30 mW/cm2)
Device: KXL System (45 mW/cm2)
Drug: riboflavin ophthalmic solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, 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 or Corneal Ectasia After Refractive Surgery

Resource links provided by NLM:


Further study details as provided by American-European Congress of Ophthalmic Surgery:

Primary Outcome Measures:
  • Mean change in maximum corneal curvature (Kmax) from baseline [ Time Frame: Month 6 or 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of treatment groups within each treatment indication [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 1719
Study Start Date: July 2012
Estimated Study Completion Date: August 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VibeX Treatment Group A
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
Device: KXL System (15 mW/cm2)
UVA irradiation for 8 minutes at 15 mW/cm2
Drug: riboflavin ophthalmic solution
Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX
Active Comparator: VibeX Treatment Group B
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
Device: KXL System (30 mW/cm2)
UVA irradiation for 4 minutes at 30 mW/cm2
Drug: riboflavin ophthalmic solution
Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX
Active Comparator: VibeX Treatment Group C
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)
UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2
Drug: riboflavin ophthalmic solution
Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (all subjects):

  1. Be at least 12 years of age, male or female, of any race;
  2. 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;
  3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
  4. 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);
  5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;
  6. Presence of central or inferior steepening on the topographic map;
  7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);
  8. 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;

    Inclusion Criteria (keratoconus subjects only):

  9. Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;
  10. Having topographic evidence of keratoconus with a diagnosis of mild, moderate or severe keratoconus defined as the following:

    • Mild Keratoconus

      1. Axial topography consistent with keratoconus
      2. Flat keratometry reading ≤ 51.00 D on topography map
    • Moderate Keratoconus

      1. Axial topography consistent with keratoconus
      2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on topography map
    • Severe Keratoconus:

      1. Axial topography consistent with keratoconus with marked areas of steepening
      2. Flat keratometry reading ≥ 56.01 D on topography map

    Inclusion Criteria (corneal ectasia subjects only):

  11. Having a diagnosis of corneal ectasia after refractive surgery;
  12. Having axial topography consistent with ectasia;

Exclusion Criteria (all subjects):

  1. Contraindications, sensitivity or known allergy to the test article(s) or their components;
  2. 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;
  3. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated;
  4. Eyes which are aphakic;
  5. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
  6. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
    2. 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;
  7. A history of delayed epithelial healing in the eye(s) to be treated;
  8. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
  9. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
  10. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
  11. A history of previous corneal crosslinking treatment in the eye to be treated;
  12. 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;
  13. 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;
  14. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated;
  15. In addition, the Investigator may exclude or discontinue any subject for any sound medical reason;

    Exclusion Criteria (Keratoconus subjects only):

  16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459679

  Hide Study Locations
Locations
United States, Alabama
John Parker
Birmingham, Alabama, United States, 35233
United States, Arizona
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
United States, California
Advanced Vision Care
Los Angeles, California, United States, 90067
Stanford University School of Medicine
Palo Alto, California, United States, 94303
Grutzmacher, Lewis and Sierra
Sacramento, California, United States, 95815
Center for Sight
Sacramento, California, United States, 95816
Newman Lasik Centers
Sacramento, California, United States, 95821
Batra Vision Medical Group
San Leandro, California, United States, 94578
Delta Eye Medical Group
Stockton, California, United States, 95207
Kaiser Permanente - Kaiser Network Patients in Northern California Only
Walnut Creek, California, United States, 94598
United States, Colorado
Mile High Corneal Specialists, PC
Denver, Colorado, United States, 80210
United States, Connecticut
Manchester Ophthalmology
Manchester, Connecticut, United States, 06040
Eye Physicians and Surgeons, PC
Milford, Connecticut, United States, 06460
United States, Florida
TLC of Miami The Laser Center of Coral Gables
Coral Gables, Florida, United States, 33134
Delray Eye Associates, PA
Delray Beach, Florida, United States, 33484
Braverman Eye Center
Hallandale Beach, Florida, United States, 33009
The Eye Institute of West Florida
Largo, Florida, United States, 33770
Herschel Lasik
Orlando, Florida, United States, 32803
LCA-Vision Inc
Tampa, Florida, United States, 33607
United States, Illinois
Quantum Vision Centers
Belleville, Illinois, United States, 62226
United States, Iowa
University of Iowa Hospitals and Clinics
Coralville, Iowa, United States, 52241
United States, Kansas
Kansas LasikPlus, P.A.
Leawood, Kansas, United States, 66211
Grene Vision Group
Wichita, Kansas, United States, 67208
United States, Kentucky
LaskiPlus Vision Center
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70115
United States, Maine
Eyecare Medical Group
Portland, Maine, United States, 04102
United States, Maryland
GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants
Baltimore, Maryland, United States, 21204
Solomon Eye Physicians and Surgeons
Bowie, Maryland, United States, 20716
Eye Doctors of Washington
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston Eye Group
Brookline, Massachusetts, United States, 02446
Ophthalmic Consultants of Boston
Waltham, Massachusetts, United States, 02451
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Henry Ford Health System
Detroit, Michigan, United States, 48202
Verdier Eye Center P.L.C.
Grand Rapids, Michigan, United States, 49546
Michigan Cornea Consultants
Southfield, Michigan, United States, 48034
United States, Minnesota
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
United States, Mississippi
Eye Surgery and Laser Center
Madison, Mississippi, United States, 39110
United States, Missouri
Pepose Vision Institute/ Lifelong Vision Foundation
Chesterfield, Missouri, United States, 63017
Ophthamology Consultants LLC
St. Louis, Missouri, United States, 63131
United States, Montana
The Eye Clinic Surgicenter
Billings, Montana, United States, 59102
United States, Nebraska
Eye Surgical Associates
Lincoln, Nebraska, United States, 68506
Kugler Vision, PC
Omaha, Nebraska, United States, 68144
United States, Nevada
Wellish Vision Institute
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Princeton Eye Group
Princeton, New Jersey, United States, 08540
United States, New Mexico
Eye Associates of New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
CNY Eye Care
De Witt, New York, United States, 13214
North Shore LIJ Health Systems
Great Neck, New York, United States, 11021
Ramapo Ophthalmology Associates, LLP
Pomona, New York, United States, 10970
United States, North Carolina
Carolina Vision Center
Fayetteville, North Carolina, United States, 28304
United States, North Dakota
Bagan Strinden Vision
Fargo, North Dakota, United States, 58103
United States, Ohio
Comprehensive Eye Care of Central Ohio
Westerville, Ohio, United States, 43082
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States, 97210
Casey Eye Institute/OHSU
Portland, Oregon, United States, 97239
United States, Pennsylvania
Ophthalmic Partners of PA, P.C.
Bala Cynwyd, Pennsylvania, United States, 19004
Schein Ernst Eye Associates
Harrisburg, Pennsylvania, United States, 17110
Scheie Eye Institute, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Corneal Associates, Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Northeastern Eye Institute
Scranton, Pennsylvania, United States, 18503
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
Wright Vision Center
Rapid City, South Dakota, United States, 57701
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Loden Vision Center
Goodlettsville, Tennessee, United States, 37072
Wang Vision Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Dell Laser Consultants
Austin, Texas, United States, 78746
Buena Vista Eyecare
El Paso, Texas, United States, 79902
Eye Consultants of Texas
Grapevine, Texas, United States, 76051
Berkeley Eye Center
Houston, Texas, United States, 77027
Slade and Baker Vision Center
Houston, Texas, United States, 77027
Focal Point Vision
San Antonio, Texas, United States, 78229
United States, Utah
Hoopes Vision
Draper, Utah, United States, 84020
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
University of Utah Dept. of Ophthalmology & Visual Sciences
Salt Lake City, Utah, United States, 84132
United States, Virginia
Silk Vision & Surgical Center
Annandale, Virginia, United States, 22003
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Commonwealth Eye Associates
Richmond, Virginia, United States, 23238
Eye Care Center of Virginia
Richmond, Virginia, United States, 23294
Beach Eye Care
Virginia Beach, Virginia, United States, 23454
United States, Washington
Evergreen Eye Center
Federal Way, Washington, United States, 98003
United States, Wisconsin
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, United States, 54601
Dean Foundation for Health, Research and Education, Inc.
Madison, Wisconsin, United States, 43715
Puerto Rico
Lilia Rivera
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
American-European Congress of Ophthalmic Surgery
Investigators
Principal Investigator: John Vukich, MD American-European Congress of Ophthalmic Surgery
  More Information

Responsible Party: American-European Congress of Ophthalmic Surgery
ClinicalTrials.gov Identifier: NCT01459679     History of Changes
Other Study ID Numbers: ACOS-KXL-001 
Study First Received: September 19, 2011
Last Updated: June 27, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Ophthalmic Solutions
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 25, 2016