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

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A Three-year Update. PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus Corneal Biomechanical Properties and Anterior Segment Parameters, in Forme Fruste Keratoconus Collagen Cross-linking in Keratoconus Tobacco Smoking Among Crosslinked-keratoconus Patients Treatment of Keratoconus With Advanced CXL-II MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus Astigmatic Vector Analysis of Posterior Cornea – a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas Management of Patients With Keratoconus With Intacs Collagen Crosslinking for Keratoconus – a Randomized Controlled Clinical Trial Corneal Tissue Inlay for Keratoconus The Role of Antioxidant Supplementation in Keratoconus Patients Epi-On Corneal Crosslinking for Keratoconus Treatment of Keratoconus With PALK Versus PK Conventional Collagen Crosslinking in Young Keratoconus Corneal Sensitivity Cross-linking Keratoconus Corneal Epithelial and Stromal Thickness Distribution in Keratoconus Treatment of Keratoconus With Advanced Corneal Crosslinking Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus Corneal Stroma Implantation for the Treatment of Keratoconus Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously) Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus Prevalence of Keratoconus in Inflammatory Bowel Diseases Keratoconus Detection by Ultrasound Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus Variability of Pentacam-derived Back Elevation Measurements in Keratoconus and Cross-linked Corneas Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus Eye Rubbing and Keratoconus in Montpellier CHU Orthokeratology for Keratoconus Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus Intacs for Keratoconus Intacs for Keratoconus The Homburg Keratoconus Center (HKC) Evaluation of Tomographic and Genetic Aspects of Keratoconus Patients Compared to Sounds Corneas Prevelance of Keratoconus Astigmatism in Keratoconus Patients Measurement of High Order Aberrations in Late Stages Keratoconus Retrospective Digital Computer Analysis of Keratoconus Evolution – REDCAKE Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus Identification and Validation of Functional Biomarkers for Keratoconus

Brief Title

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

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change in Kmax from baseline


Condition

Keratoconus

Intervention

riboflavin solution

Study Arms / Comparison Groups

 riboflavin solution and KXL System
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

92

Start Date

November 2013

Completion Date

April 2017

Primary Completion Date

March 2016

Eligibility Criteria

        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

               4. A decrease ≥ 0.1 mm in the BOZR (Back Optical Zone Radius) in rigid contact lens
                  wearers where other information is not available

          6. 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 Pentacam keratometry reading ≤ 51.00D

               -  Moderate Keratoconus:

                    1. Axial topography consistent with keratoconus

                    2. Flat Pentacam keratometry reading > 51.00 D and ≤ 56.00 D or astigmatism ≥
                       8.00 D

               -  Severe Keratoconus:

                    1. Axial topography consistent with keratoconus with marked areas of steepening

                    2. Flat Pentacam keratometry reading > 56.00 D

          7. Presence of central or inferior steepening on the Pentacam map;

          8. Have a maximum corneal curvature, as measured by Kmax, of ≥ 47.00 D;

          9. BSCVA of ≥ 1 letter and ≤ 80 letters on ETDRS chart;

         10. 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;

         11. 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.

        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:

               1. 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.);

               2. 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;

         10. A history of delayed epithelial healing in the eye to be treated;

         11. Subjects with nystagmus or any other condition that would prevent a steady gaze during
             the treatment or other diagnostic tests;

         12. Subjects with a current condition that, in the investigator's opinion, would interfere
             with or prolong epithelial healing;

         13. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the
             cross-linking treatment;

         14. A history of previous corneal crosslinking treatment in the eye to be treated;

         15. 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.

         16. The Investigator may exclude or discontinue any subject for any sound medical reason.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Hersh, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01972854

Organization ID

KXL-005


Responsible Party

Sponsor

Study Sponsor

Glaukos Corporation


Study Sponsor

Peter Hersh, M.D., Study Director, Glaukos Corporation


Verification Date

April 2021