Epi-On Corneal Crosslinking for Keratoconus

NCT03245853 | Completed Phase 4 FDA Drug

• 1 other identifier: 20170265
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

Conditions

Keratoconus; Keratoconus, Unstable

Keywords

Keratoconus; Corneal Crosslinking; CXL

Outcome Measures

Primary Outcomes (1)

• Maximum keratometric change

  Change from baseline keratometric maximum over time.

  12 months

Secondary Outcomes (1)

• Visual acuity change

  12 months

Study Arms (1)

Treatment

OTHER

Treatment as per protocol, there is no placebo arm.

Drug: Riboflavin 5'-Phosphate

Interventions

Riboflavin 5'-Phosphate DRUG

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.

Also known as: Photrexa

Treatment

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comprehensive EyeCare of Central Ohio: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Flavin Mononucleotide

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Riboflavin; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Pigments, Biological; Biological Factors

Study Officials

• Kenneth A Beckman, M.D.

  Comprehensive EyeCare of Central Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 10, 2017
• Study Start: July 18, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 30, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)