Clinical Trials/NCT01459679

NCT01459679

Terminated

Phase 3

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

American-European Congress of Ophthalmic Surgery83 sites in 1 country1,721 target enrollmentJuly 2012

ConditionsKeratoconus Corneal Ectasia

InterventionsKXL System (30 mW/cm2)KXL System (15 mW/cm2)riboflavin ophthalmic solution KXL System (45 mW/cm2)

Drugsriboflavin ophthalmic solution

Overview

Phase: Phase 3
Intervention: KXL System (30 mW/cm2)
Conditions: Keratoconus
Sponsor: American-European Congress of Ophthalmic Surgery
Enrollment: 1721
Locations: 83
Primary Endpoint: Mean change in maximum corneal curvature (Kmax) from baseline
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

August 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

American-European Congress of Ophthalmic Surgery

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

VibeX Treatment Group B

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

Intervention: KXL System (30 mW/cm2)

VibeX Treatment Group A

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Intervention: KXL System (15 mW/cm2)

VibeX Treatment Group A

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Intervention: riboflavin ophthalmic solution

VibeX Treatment Group B

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

Intervention: riboflavin ophthalmic solution

VibeX Treatment Group C

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

Intervention: KXL System (45 mW/cm2)

VibeX Treatment Group C

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

Intervention: riboflavin ophthalmic solution

Outcomes

Primary Outcomes

Mean change in maximum corneal curvature (Kmax) from baseline

Time Frame: Month 6 or 12

Secondary Outcomes

Comparison of treatment groups within each treatment indication(Month 6 and 12)

Study Sites (83)

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