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

Keratoconus Clinical Trial

Official title:

Multi-Center, Randomized, Controlled Evaluation of the Safety & 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01459679
• Other study ID #: ACOS-KXL-001
• Status: Terminated
• Phase: Phase 3
• Start date: July 2012
• Est. completion date: August 2016

Study information

• Verified date: June 2018
• Source: American-European Congress of Ophthalmic Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1721
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Diseases
• Corneal Ectasia
• Keratoconus

Intervention

Device:
• KXL System (15 mW/cm2)
UVA irradiation for 8 minutes at 15 mW/cm2
• KXL System (30 mW/cm2)
UVA irradiation for 4 minutes at 30 mW/cm2
• 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

Locations

Country	Name	City	State
Puerto Rico	Lilia Rivera	San Juan
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Silk Vision & Surgical Center	Annandale	Virginia
United States	Dell Laser Consultants	Austin	Texas
United States	Ophthalmic Partners of PA, P.C.	Bala-Cynwyd	Pennsylvania
United States	GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants	Baltimore	Maryland
United States	Quantum Vision Centers	Belleville	Illinois
United States	The Eye Clinic Surgicenter	Billings	Montana
United States	John Parker	Birmingham	Alabama
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Solomon Eye Physicians and Surgeons	Bowie	Maryland
United States	Boston Eye Group	Brookline	Massachusetts
United States	Pepose Vision Institute/ Lifelong Vision Foundation	Chesterfield	Missouri
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	TLC of Miami The Laser Center of Coral Gables	Coral Gables	Florida
United States	University of Iowa Hospitals and Clinics	Coralville	Iowa
United States	CNY Eye Care	De Witt	New York
United States	Delray Eye Associates, PA	Delray Beach	Florida
United States	Mile High Corneal Specialists, PC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Hoopes Vision	Draper	Utah
United States	Buena Vista Eyecare	El Paso	Texas
United States	Bagan Strinden Vision	Fargo	North Dakota
United States	Carolina Vision Center	Fayetteville	North Carolina
United States	Evergreen Eye Center	Federal Way	Washington
United States	Loden Vision Center	Goodlettsville	Tennessee
United States	Verdier Eye Center P.L.C.	Grand Rapids	Michigan
United States	Eye Consultants of Texas	Grapevine	Texas
United States	North Shore LIJ Health Systems	Great Neck	New York
United States	Braverman Eye Center	Hallandale Beach	Florida
United States	Schein Ernst Eye Associates	Harrisburg	Pennsylvania
United States	Berkeley Eye Center	Houston	Texas
United States	Slade and Baker Vision Center	Houston	Texas
United States	Gundersen Clinic, Ltd.	La Crosse	Wisconsin
United States	The Eye Institute of West Florida	Largo	Florida
United States	Wellish Vision Institute	Las Vegas	Nevada
United States	Kansas LasikPlus, P.A.	Leawood	Kansas
United States	Eye Surgical Associates	Lincoln	Nebraska
United States	Advanced Vision Care	Los Angeles	California
United States	LaskiPlus Vision Center	Louisville	Kentucky
United States	Dean Foundation for Health, Research and Education, Inc.	Madison	Wisconsin
United States	Eye Surgery and Laser Center	Madison	Mississippi
United States	Manchester Ophthalmology	Manchester	Connecticut
United States	Eye Physicians and Surgeons, PC	Milford	Connecticut
United States	Wang Vision Institute	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Kugler Vision, PC	Omaha	Nebraska
United States	Herschel Lasik	Orlando	Florida
United States	Stanford University School of Medicine	Palo Alto	California
United States	Corneal Associates, Wills Eye Institute	Philadelphia	Pennsylvania
United States	Scheie Eye Institute, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona
United States	Ramapo Ophthalmology Associates, LLP	Pomona	New York
United States	Casey Eye Institute/OHSU	Portland	Oregon
United States	Devers Eye Institute	Portland	Oregon
United States	Eyecare Medical Group	Portland	Maine
United States	Princeton Eye Group	Princeton	New Jersey
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Wright Vision Center	Rapid City	South Dakota
United States	Commonwealth Eye Associates	Richmond	Virginia
United States	Eye Care Center of Virginia	Richmond	Virginia
United States	Center for Sight	Sacramento	California
United States	Grutzmacher, Lewis and Sierra	Sacramento	California
United States	Newman Lasik Centers	Sacramento	California
United States	Ophthamology Consultants LLC	Saint Louis	Missouri
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	University of Utah Dept. of Ophthalmology & Visual Sciences	Salt Lake City	Utah
United States	Focal Point Vision	San Antonio	Texas
United States	Batra Vision Medical Group	San Leandro	California
United States	Northeastern Eye Institute	Scranton	Pennsylvania
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Michigan Cornea Consultants	Southfield	Michigan
United States	Delta Eye Medical Group	Stockton	California
United States	LCA-Vision Inc	Tampa	Florida
United States	Beach Eye Care	Virginia Beach	Virginia
United States	Kaiser Permanente - Kaiser Network Patients in Northern California Only	Walnut Creek	California
United States	Ophthalmic Consultants of Boston	Waltham	Massachusetts
United States	Comprehensive Eye Care of Central Ohio	Westerville	Ohio
United States	Grene Vision Group	Wichita	Kansas
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
American-European Congress of Ophthalmic Surgery

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in maximum corneal curvature (Kmax) from baseline		Month 6 or 12
Secondary	Comparison of treatment groups within each treatment indication		Month 6 and 12