NCT03442751

Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus

A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.

Detailed description

Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change in Kmax from baseline to Month 6.

Conditions

• Progressive Keratoconus

Interventions

Type	Name	Description
DRUG	Test Article A	Riboflavin Ophthalmic Solution A
DRUG	Test Article B	Riboflavin Ophthalmic Solution B
DRUG	Placebo	Placebo Vehicle of Test Article
DEVICE	KXL medical device system	Mock UVA light source
DEVICE	KXL medical device system	Cross-linking UVA light source

Timeline

• Start date: 2018-04-06
• Primary completion: 2019-11-01
• Completion: 2020-08-10
• First posted: 2018-02-22
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study