Corneal Collagen Cross-Linking Techniques for Keratoconus

Overseen By Jasmine Ly, OD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Center for Sight, Sacramento, CA

Disqualifiers: Corneal transplant, Prior CXL, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

550 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals at least 12 years old with keratoconus or other corneal ectatic disorders. Participants must provide consent, have specific topography map changes, and be willing to use birth control if applicable. Those with prior CXL treatment, corneal transplants, certain ocular conditions, allergies to study materials, or inadequate corneal thickness are excluded.

Inclusion Criteria

I have been diagnosed with keratoconus or a similar eye condition.

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 for one month following treatment

Presence of central or inferior steepening on the topography map

Exclusion Criteria

Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices

A known contraindication, sensitivity, or allergy to the test article or its components or to study medications

A specific eye treatment technique cannot be used on me, as per my doctor's advice.

Treatment Details

Interventions

• Epi-OFF
• Epi-ON
• Ricrolin+
• VEGA UV-A system

Trial Overview The study compares two techniques of Corneal Collagen Cross-Linking (CXL) treatments for strengthening the cornea: Epi-OFF (removal of the outer layer of the cornea) and Epi-ON (outer layer left intact), both using Ricrolin+ and VEGA UV-A system in a randomized design.

Participant Groups

Group I: Epi-ON CXL Active Control 2 Interventions

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.

Group II: Epi-OFF CXL Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Center for Sight, Sacramento, CA

Lead Sponsor

Trials

1

Recruited

550+