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Safety and Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT01972854•Glaukos Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must meet all of the following criteria in order to be enrolled in the trial:
•1. Be at least 12 years of age, male or female, of any race;
•2. 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;
•3. 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;
•4. 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);
•5. 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:
•1. An increase of ≥ 1.00 D in the steepest keratometry value (ksteep)
•2. 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
•3. 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
+16 more criteria

Exclusion Criteria

•Subjects must not meet any of the following criteria to be enrolled in the trial:
•1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
•2. 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;
•3. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
•4. A history of previous corneal surgery or the insertion of Intacs in the eye to be treated;
•5. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye to be treated;
•6. Corneal pachymetry that is \< 375 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
•7. Eyes which are aphakic;
•8. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
•9. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
+9 more criteria

Locations (11)

UC Irvine Department of Ophthalmology

Irvine, California, United States

Gordon -Weiss Vision Institute

San Diego, California, United States

Price Vision Group

Indianapolis, Indiana, United States

Durrie Vision

Overland Park, Kansas, United States

Ophthalmic Consultants of Boston

Waltham, Massachusetts, United States

Hersh Vision Group

Teaneck, New Jersey, United States

UPMC Eye Center

Pittsburgh, Pennsylvania, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Focal Point Vision

San Antonio, Texas, United States

Hoopes Vision

Draper, Utah, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

March 1, 2016

Completion Date

April 1, 2017

Last Updated

April 26, 2021

Enrollment

ACTUAL participants

Conditions

Keratoconus

Interventions

riboflavin solution

DRUG

placebo solution

DRUG

KXL System

DEVICE

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

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Keratoconus

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RECRUITINGNA

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

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Keratoconus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

OCT in Diagnosis of Irregular Corneas

Scleral Lens Fitting Using Wide-Field OCT