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

Phase 3

Terminated

• Conditions: Keratoconus; Corneal Ectasia
• Interventions: Device: KXL System (45 mW/cm2); Device: KXL System (30 mW/cm2); Device: KXL System (15 mW/cm2); Drug: riboflavin ophthalmic solution

• Registration Number: NCT01459679
• Lead Sponsor: American-European Congress of Ophthalmic Surgery

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-26
• Study Start: 2012-07
• Primary Completion: 2016-01
• Study Completion: 2016-08
• Status Verified: 2018-06
• Disposition First Submitted: 2018-06-27
• Disposition First Submitted QC: 2018-06-28
• Last Update Submitted: 2018-07-02
• Disposition First Posted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1721

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VibeX Treatment Group C	riboflavin ophthalmic solution	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
VibeX Treatment Group C	KXL System (45 mW/cm2)	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
VibeX Treatment Group A	riboflavin ophthalmic solution	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
VibeX Treatment Group B	KXL System (30 mW/cm2)	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
VibeX Treatment Group B	riboflavin ophthalmic solution	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
VibeX Treatment Group A	KXL System (15 mW/cm2)	Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Primary Outcome Measures

Name	Time	Method
Mean change in maximum corneal curvature (Kmax) from baseline	Month 6 or 12

Secondary Outcome Measures

Name	Time	Method
Comparison of treatment groups within each treatment indication	Month 6 and 12

Trial Locations

Locations (83)

John Parker; 🇺🇸 Birmingham, Alabama, United States

Barnet Dulaney Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Advanced Vision Care; 🇺🇸 Los Angeles, California, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Grutzmacher, Lewis and Sierra; 🇺🇸 Sacramento, California, United States

Center for Sight; 🇺🇸 Sacramento, California, United States

Newman Lasik Centers; 🇺🇸 Sacramento, California, United States

Batra Vision Medical Group; 🇺🇸 San Leandro, California, United States

Delta Eye Medical Group; 🇺🇸 Stockton, California, United States

Kaiser Permanente - Kaiser Network Patients in Northern California Only; 🇺🇸 Walnut Creek, California, United States

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