NCT03245853

Epi-On Corneal Crosslinking for Keratoconus

Epithelium-On Corneal Collagen Crosslinking for Keratoconus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Comprehensive EyeCare of Central Ohio · Academic / Other
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

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).

Conditions

• Keratoconus
• Keratoconus, Unstable

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-18
• Primary completion: 2019-09-01
• Completion: 2019-09-30
• First posted: 2017-08-10
• Last updated: 2020-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study