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KeratoconusPhase 3NCT01459679

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

A Phase 3 study testing KXL System (15 mW/cm2), KXL System (30 mW/cm2) and KXL System (45 mW/cm2) in people with Keratoconus and Corneal Ectasia, run by American-European Congress of Ophthalmic Surgery at 83 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Keratoconus, Corneal Ectasia
What is being tested?
KXL System (15 mW/cm2), KXL System (30 mW/cm2) and KXL System (45 mW/cm2)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,721 participants
Where
83 sitesin 2 countries
Study dates
Jul 2012to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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
  • Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on topography map
  • Severe Keratoconus:
  • Axial topography consistent with keratoconus with marked areas of steepening
  • Flat keratometry reading ≥ 56.01 D on topography map
  • Having a diagnosis of corneal ectasia after refractive surgery;
  • Having axial topography consistent with ectasia;

Who cannot join

  • 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:
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  • 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;
  • A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated;
  • In addition, the Investigator may exclude or discontinue any subject for any sound medical reason;
  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.

Trial locations and contacts

83 sites in 2 countries.

83 sites in 2 countries

United States82 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • Silk Vision & Surgical Center

    Annandale, Virginia, 22003

  • Dell Laser Consultants

    Austin, Texas, 78746

  • Ophthalmic Partners of PA, P.C.

    Bala-Cynwyd, Pennsylvania, 19004

  • GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants

    Baltimore, Maryland, 21204

  • Quantum Vision Centers

    Belleville, Illinois, 62226

  • The Eye Clinic Surgicenter

    Billings, Montana, 59102

  • John Parker

    Birmingham, Alabama, 35233

  • Chu Vision Institute

    Bloomington, Minnesota, 55420

  • Solomon Eye Physicians and Surgeons

    Bowie, Maryland, 20716

  • Boston Eye Group

    Brookline, Massachusetts, 02446

  • Pepose Vision Institute/ Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

  • Eye Doctors of Washington

    Chevy Chase, Maryland, 20815

  • TLC of Miami The Laser Center of Coral Gables

    Coral Gables, Florida, 33134

  • University of Iowa Hospitals and Clinics

    Coralville, Iowa, 52241

  • CNY Eye Care

    De Witt, New York, 13214

  • Delray Eye Associates, PA

    Delray Beach, Florida, 33484

  • Mile High Corneal Specialists, PC

    Denver, Colorado, 80210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Hoopes Vision

    Draper, Utah, 84020

  • Buena Vista Eyecare

    El Paso, Texas, 79902

  • Bagan Strinden Vision

    Fargo, North Dakota, 58103

  • Carolina Vision Center

    Fayetteville, North Carolina, 28304

  • Evergreen Eye Center

    Federal Way, Washington, 98003

  • Loden Vision Center

    Goodlettsville, Tennessee, 37072

  • Verdier Eye Center P.L.C.

    Grand Rapids, Michigan, 49546

  • Eye Consultants of Texas

    Grapevine, Texas, 76051

  • North Shore LIJ Health Systems

    Great Neck, New York, 11021

  • Braverman Eye Center

    Hallandale, Florida, 33009

  • Schein Ernst Eye Associates

    Harrisburg, Pennsylvania, 17110

  • Berkeley Eye Center

    Houston, Texas, 77027

  • Slade and Baker Vision Center

    Houston, Texas, 77027

  • Gundersen Clinic, Ltd.

    La Crosse, Wisconsin, 54601

  • The Eye Institute of West Florida

    Largo, Florida, 33770

  • Wellish Vision Institute

    Las Vegas, Nevada, 89119

  • Kansas LasikPlus, P.A.

    Leawood, Kansas, 66211

  • Eye Surgical Associates

    Lincoln, Nebraska, 68506

  • Advanced Vision Care

    Los Angeles, California, 90067

  • LaskiPlus Vision Center

    Louisville, Kentucky, 40207

  • Eye Surgery and Laser Center

    Madison, Mississippi, 39110

  • Dean Foundation for Health, Research and Education, Inc.

    Madison, Wisconsin, 43715

  • Manchester Ophthalmology

    Manchester, Connecticut, 06040

  • Eye Physicians and Surgeons, PC

    Milford, Connecticut, 06460

  • Wang Vision Institute

    Nashville, Tennessee, 37203

  • Ochsner Medical Center

    New Orleans, Louisiana, 70115

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Kugler Vision, PC

    Omaha, Nebraska, 68144

  • Herschel Lasik

    Orlando, Florida, 32803

  • Stanford University School of Medicine

    Palo Alto, California, 94303

  • Scheie Eye Institute, University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Corneal Associates, Wills Eye Institute

    Philadelphia, Pennsylvania, 19107

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona, 85016

  • Ramapo Ophthalmology Associates, LLP

    Pomona, New York, 10970

  • Eyecare Medical Group

    Portland, Maine, 04102

  • Devers Eye Institute

    Portland, Oregon, 97210

  • Casey Eye Institute/OHSU

    Portland, Oregon, 97239

  • Princeton Eye Group

    Princeton, New Jersey, 08540

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Wright Vision Center

    Rapid City, South Dakota, 57701

  • Commonwealth Eye Associates

    Richmond, Virginia, 23238

  • Eye Care Center of Virginia

    Richmond, Virginia, 23294

  • Grutzmacher, Lewis and Sierra

    Sacramento, California, 95815

  • Center for Sight

    Sacramento, California, 95816

  • Newman Lasik Centers

    Sacramento, California, 95821

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

  • University of Utah Dept. of Ophthalmology & Visual Sciences

    Salt Lake City, Utah, 84132

  • Focal Point Vision

    San Antonio, Texas, 78229

  • Batra Vision Medical Group

    San Leandro, California, 94578

  • Northeastern Eye Institute

    Scranton, Pennsylvania, 18503

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

  • Michigan Cornea Consultants

    Southfield, Michigan, 48034

  • Ophthamology Consultants LLC

    St Louis, Missouri, 63131

  • Delta Eye Medical Group

    Stockton, California, 95207

  • LCA-Vision Inc

    Tampa, Florida, 33607

  • Beach Eye Care

    Virginia Beach, Virginia, 23454

  • Kaiser Permanente - Kaiser Network Patients in Northern California Only

    Walnut Creek, California, 94598

  • Ophthalmic Consultants of Boston

    Waltham, Massachusetts, 02451

  • Comprehensive Eye Care of Central Ohio

    Westerville, Ohio, 43082

  • Grene Vision Group

    Wichita, Kansas, 67208

  • Bucci Laser Vision Institute

    Wilkes-Barre, Pennsylvania, 18702

Other trials in United States

Puerto Rico1 site

  • Lilia Rivera

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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.

Being tested
KXL System (15 mW/cm2), KXL System (30 mW/cm2), KXL System (45 mW/cm2), riboflavin ophthalmic solution
Medical subject headings
Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KXL System (15 mW/cm2)Device

    UVA irradiation for 8 minutes at 15 mW/cm2

  • KXL System (30 mW/cm2)Device

    UVA irradiation for 4 minutes at 30 mW/cm2

  • KXL System (45 mW/cm2)Device

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

  • riboflavin ophthalmic solutionDrug

    Also called VibeX

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

Study groups in NCT01459679
Study groupRoleWhat they receive
VibeX Treatment Group AActive comparatorCorneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
Receives: Device: KXL System (15 mW/cm2); Drug: riboflavin ophthalmic solution
VibeX Treatment Group BActive comparatorCorneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
Receives: Device: KXL System (30 mW/cm2); Drug: riboflavin ophthalmic solution
VibeX Treatment Group CActive comparatorCorneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
Receives: Device: KXL System (45 mW/cm2); Drug: riboflavin ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in maximum corneal curvature (Kmax) from baseline

    Measured: Month 6 or 12

Secondary outcomes (1)

  1. Comparison of treatment groups within each treatment indication

    Measured: Month 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,721 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01459679
Sponsor's protocol ID
ACOS-KXL-001
Status last verified
Jun 2018
First submitted
19 Sep 2011
Last updated
5 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KXL System (15 mW/cm2), KXL System (30 mW/cm2) and KXL System (45 mW/cm2) in people with Keratoconus and Corneal Ectasia, run by American-European Congress of Ophthalmic Surgery at 83 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in maximum corneal curvature (Kmax) from baseline (time frame: Month 6 or 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01459679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.

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