Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

NCT04897503 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: CLEI - ISO-CXL-001
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Conditions

Keratoconus; Corneal Ectasia

Keywords

keratoconus; corneal ectasia; collagen crosslinking; riboflavin; cornea; ultraviolet; crosslinking; corneal crosslinking

Outcome Measures

Primary Outcomes (1)

• Maximum keratometry

  The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

  12 months

Secondary Outcomes (1)

• Visual acuity

  1 year

Study Arms (2)

CXL using Riboflavin/Dextran solution

ACTIVE COMPARATOR

Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran

Drug: Riboflavin

CXL usinng Riboflavin/Methylcellulose solution

ACTIVE COMPARATOR

Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

Drug: Riboflavin

Interventions

Riboflavin DRUG

Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

CXL using Riboflavin/Dextran solution; CXL usinng Riboflavin/Methylcellulose solution

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
• Presence of central or inferior steepening on the Pentacam map
• Axial topography consistent with keratoconus or post-surgical corneal ectasia
• Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

You may not qualify if:

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
• Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: 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 CXL treatment zone
• A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
• Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institue - Hersh Vision Group

Teaneck, New Jersey, 07666, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus; Corneal Diseases

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Peter S Hersh, MD

  Cornea and Laser Eye Institute Hersh Vision Group

  STUDY DIRECTOR

• Steven A Greenstein, MD

  Cornea and Laser Eye Institute, Hersh Vision Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BethAnn Furlong-Hibbert

CONTACT

1 201 692-9434; bafhibbert@yahoo.com

Stacey Lazar

CONTACT

1 201 692-9434; slazar@vision-institute.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: April 16, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

US (1)