NCT01459679

Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,721 (actual)
• Sponsor: American-European Congress of Ophthalmic Surgery · Network
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Keratoconus
• Corneal Ectasia

Interventions

Type	Name	Description
DEVICE	KXL System (15 mW/cm2)	UVA irradiation for 8 minutes at 15 mW/cm2
DEVICE	KXL System (30 mW/cm2)	UVA irradiation for 4 minutes at 30 mW/cm2
DEVICE	KXL System (45 mW/cm2)	UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2
DRUG	riboflavin ophthalmic solution	Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-01-01
• Completion: 2016-08-01
• First posted: 2011-10-26
• Last updated: 2018-07-05

Locations

83 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study