Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

NCT04905108 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: TE-CXL-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.

Conditions

Keratoconus; Corneal Ectasia

Keywords

keratoconus; corneal ectasia; collagen crosslinking; riboflavin; 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)

• Mean keratometry

  1 year

Study Arms (2)

Riboflavin drop every 2 minutes

ACTIVE COMPARATOR

Administration of one drop of Riboflavin every 2 minutes during UV exposure

Drug: Riboflavin

Riboflavin drop every 10 minutes

ACTIVE COMPARATOR

Administration of one drop of Riboflavin every 10 minutes during UV exposure

Drug: Riboflavin

Interventions

Riboflavin DRUG

Administration of riboflavin one drop every 2 minutes during UVA exposure

Riboflavin drop every 10 minutes

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 (e.g., LASIK, photorefractive keratectomy \[PRK\])
• 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 lenses 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 measuring 300 microns or less 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 scaring 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 Institute, Hersh Vision Group

Teaneck, New Jersey, 07666, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; 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

(201) 692-9434; bfurlong-hibbert@vision-institute.com

Stacey Lazar

CONTACT

(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 24, 2021
• First Posted: May 27, 2021
• Study Start: June 2, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

US (1)