NCT01972854

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

October 25, 2013

Last Update Submit

April 22, 2021

Conditions

Keratoconus

Keywords

keratoconuscross-linkingKXL

Outcome Measures

Primary Outcomes (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.

    12 months

Study Arms (2)

riboflavin solution and KXL System

EXPERIMENTAL

The 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.

Drug: riboflavin solutionDevice: KXL System

placebo solution and KXL System

PLACEBO COMPARATOR

The 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.

Drug: placebo solutionDevice: KXL System

Interventions

riboflavin solutionDRUG

0.12% riboflavin ophthalmic solution

Also known as: VibeX
riboflavin solution and KXL System
placebo solutionDRUG

0.0% riboflavin ophthalmic solution

Also known as: placebo
placebo solution and KXL System
KXL SystemDEVICE

30mW/cm2

Also known as: UVA Irradiation
placebo solution and KXL Systemriboflavin solution and KXL System

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • \- 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
  • +11 more criteria

You may not qualify if:

  • 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;
  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UC Irvine Department of Ophthalmology

Irvine, California, 92868, United States

Location

Gordon -Weiss Vision Institute

San Diego, California, 92122, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Ophthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

Location

Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57105, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

Hoopes Vision

Draper, Utah, 84020, United States

Location

See Clearly Vision

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Peter Hersh, M.D.

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2016

Study Completion

April 1, 2017

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(11)