Epi-On Corneal Crosslinking for Keratoconus

Epithelium-On Corneal Collagen Crosslinking for Keratoconus

Epithelium-On Corneal Crosslinking for Keratoconus.

Study Overview

• Status: Completed
• Conditions: Keratoconus; Keratoconus, Unstable
• Intervention / Treatment: Drug: Riboflavin 5'-Phosphate

Detailed Description

Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination.

The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Comprehensive EyeCare of Central Ohio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry <350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.

Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Treatment; Treatment as per protocol, there is no placebo arm.

Drug: Riboflavin 5'-Phosphate; Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.; Other Names: Photrexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum keratometric change	Change from baseline keratometric maximum over time.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity change	Change from baseline uncorrected distance visual acuity and best spectacle-corrected visual acuity.	12 months

Collaborators and Investigators

• Sponsor: Comprehensive EyeCare of Central Ohio
• Collaborators: Glaukos Corporation
• Investigators: Principal Investigator: Kenneth A Beckman, M.D., Comprehensive EyeCare of Central Ohio

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Keratoconus; CXL; Corneal Crosslinking
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin; Flavin Mononucleotide
• Other Study ID Numbers: 20170265

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes