Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

NCT03858036 | Unknown Phase 3 FDA Drug FDA Device

• 1 other identifier: CFS-CXL-001
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.

Conditions

Keratoconus; Ectasia

Outcome Measures

Primary Outcomes (1)

• Mean change in corneal curvature

  Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III

  Baseline, 6 Months, and 12 Months

Secondary Outcomes (4)

• Change in manifest refraction spherical equivalent

  Baseline, 6 Months, and 12 Months

• Change in best-corrected visual acuity (BSCVA)

  Baseline, 6 Months, and 12 Months

• Change in uncorrected-visual acuity (UCVA)

  Baseline, 6 Months, and 12 Months

• Change in thinnest pachymetry

  Baseline, 6 Months, and 12 Months

Study Arms (2)

Epi-OFF CXL

ACTIVE COMPARATOR

The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.

Drug: Ricrolin+; Device: VEGA UV-A system

Epi-ON CXL

ACTIVE COMPARATOR

The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.

Drug: Ricrolin+; Device: VEGA UV-A system

Interventions

Ricrolin+ DRUG

1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.

Epi-OFF CXL; Epi-ON CXL

VEGA UV-A system DEVICE

The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.

Epi-OFF CXL; Epi-ON CXL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 12 years of age or older, male or female, of any race.
• Having a diagnosis of keratoconus or other corneal ectatic disorder.
• Presence of central or inferior steepening on the topography map.
• Axial topography consistent with keratoconus or other corneal ectatic disorder.
• For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
• Scissoring of the retinoscopic reflex
• Fleischer ring
• Vogt striae
• Corneal thinning e .Corneal scarring
• BSCVA 20/20 or worse.
• Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
• Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
• Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
• If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.

You may not qualify if:

• One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
• Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
• A history of previous corneal transplant in the study eye.
• A history of prior CXL in the study eye.
• Corneal pachymetry \< 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. \[NOTE: Eyes with corneal pachymetry between \<375 microns and 325 microns may be enrolled in the compassionate use group.\]
• Presence of Intacs or corneal rings or segments in the study eye.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
• Clinically significant corneal scarring in the treatment zone unrelated to keratoconus.
• Eyes which are aphakic.
• Eyes which are pseudophakic and do not have a UV blocking lens implanted.
• A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
• Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
• If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
• A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.

Sponsors & Collaborators

• Center for Sight, Sacramento, CA: lead

Study Sites (1)

Center for Sight

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Keratoconus; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jasmine Ly, OD

CONTACT

916-446-2020; jly@liangvision.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: February 26, 2019
• First Posted: February 28, 2019
• Study Start: March 8, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)