NCT01643226

Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DRUG	riboflavin solution	0.12% riboflavin ophthalmic solution
DRUG	placebo solution	0.0% riboflavin ophthalmic solution
DEVICE	KXL System	30 mW/cm2

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-07-01
• Completion: 2016-09-01
• First posted: 2012-07-18
• Last updated: 2021-04-26

Locations

8 sites across 1 country: United States