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KeratoconusPhase 3NCT01972854

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

A Phase 3 study testing riboflavin solution and KXL System in people with Keratoconus, run by Glaukos Corporation at 11 sites in United States.

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 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Keratoconus
What is being tested?
riboflavin solution and KXL System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
11 sitesUnited States
Study dates
Nov 2013to Apr 2017
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

  • Subjects must meet all of the following criteria in order to be enrolled in the trial:
  • Be at least 12 years of age, male or female, of any race;
  • Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) 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, including the ability to read English to complete the NEI-VFQ 25 questionnaire;
  • For females capable of becoming pregnant, agree to have urine pregnancy testing performed at Visit 2 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 Visit 2, 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);
  • Subjects > 25 years old at the time of screening of their study eye must meet the following criteria. Subjects ≤ 25 years old and all subjects who have their fellow-eye or crossover eye treated are not required to meet these criteria;
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  • Having a diagnosis of progressive keratoconus defined as one or more of the following changes over a period of 36 months or less:
  • An increase of ≥ 1.00 D in the steepest keratometry value (ksteep)
  • An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction or as evaluated by comparing eyeglass or contact lens prescriptions to current subjective manifest refraction
  • A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D in subjective manifest refraction or as evaluated by comparing eyeglass or contact lens prescriptions to current subjective manifest refraction
  • A decrease ≥ 0.1 mm in the BOZR (Back Optical Zone Radius) in rigid contact lens wearers where other information is not available
  • 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 > 51.00 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 > 56.00 D
  • Presence of central or inferior steepening on the Pentacam map;
  • Have a maximum corneal curvature, as measured by Kmax, of ≥ 47.00 D;
  • BSCVA of ≥ 1 letter and ≤ 80 letters on ETDRS chart;
  • Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the first screening refraction visit (and each subsequent Visit 1, as necessary) and must remain out until the 1 month visit is completed;
  • Contact Lens Wearers Only: Manifest refraction must be stable between two consecutive 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 Pentacam taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam. A contact lens wearer is defined as someone who has worn contact lenses in the eye to be treated in the last 30 days.

Who cannot join

  • Subjects must not meet any of the following criteria 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 during the course of the study or have a positive urine pregnancy test at Visit 2 prior to randomization or treatment of either eye;
  • 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;
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  • 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;
  • Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
  • History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, corneal melt, recurrent corneal erosion syndrome, 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;
  • Subjects with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
  • Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
  • Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment;
  • A history of previous corneal crosslinking treatment in the eye to be treated;
  • The subject should not have participated in any investigational drug or device study within 30 days of screening or be concurrently enrolled in another investigational drug or device study.
  • The Investigator may exclude or discontinue any subject for any sound medical reason.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Hoopes Vision

    Draper, Utah, 84020

  • Price Vision Group

    Indianapolis, Indiana, 46260

  • UC Irvine Department of Ophthalmology

    Irvine, California, 92868

  • See Clearly Vision

    McLean, Virginia, 22102

  • Durrie Vision

    Overland Park, Kansas, 66211

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213

  • Focal Point Vision

    San Antonio, Texas, 78229

  • Gordon -Weiss Vision Institute

    San Diego, California, 92122

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57105

  • Hersh Vision Group

    Teaneck, New Jersey, 07666

  • Ophthalmic Consultants of Boston

    Waltham, Massachusetts, 02451

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Placebo-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

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
Being tested
riboflavin solution, placebo solution, KXL System
Keywords
keratoconus, cross-linking, KXL
Medical subject headings
Keratoconus

What participants receive

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

  • riboflavin solutionDrug

    Also called VibeX

    0.12% riboflavin ophthalmic solution

  • placebo solutionDrug

    Also called placebo

    0.0% riboflavin ophthalmic solution

  • KXL SystemDevice

    Also called UVA Irradiation

    30mW/cm2

Study groups in NCT01972854
Study groupRoleWhat they receive
riboflavin solution and KXL SystemExperimentalThe cornea will receive 5 drops of VibeX (0.12% riboflavin ophthalmic solution). Five additional VibeX drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Receives: Drug: riboflavin solution; Device: KXL System
placebo solution and KXL SystemPlacebo comparatorThe cornea will receive 5 drops of placebo (0.0% riboflavin ophthalmic solution. Five additional placebo drops will be instilled every two minutes for 20 minutes. The eye will be irradiated for 8 minutes with an on/off cycle of 1 second UVA on/1 second UVA off.
Receives: Drug: placebo solution; Device: KXL System

What is being measured

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

  1. Change in Kmax from baseline

    The primary endpoint is the mean change from baseline to 12 months in maximum corneal curvature (Kmax) between the VibeX treatment group and the Placebo control group.

    Measured: 12 months

Timeline

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

  1. First posted31 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2016
  4. Study completionApr 2017

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
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972854
Sponsor's protocol ID
KXL-005
Status last verified
Apr 2021
First submitted
25 Oct 2013
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing riboflavin solution and KXL System in people with Keratoconus, run by Glaukos Corporation at 11 sites in United States.

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 26 inclusion and 19 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Change in Kmax from baseline (time frame: 12 months). 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 NCT01972854.

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 26 Apr 2021.

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