Safety and Efficacy Study for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

Phase 3

Withdrawn

• Conditions: Corneal Ectasia

• Registration Number: NCT01643252
• Lead Sponsor: Glaukos Corporation

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group	Baseline to 6 months
Safety	12 months	The primary safety endpoints are loss of BSCVA beginning at the 6 month follow-up examination, specifically, the percentage of eyes that have a loss of 15 or more letters in BSCVA on the ETDRS chart as compared to baseline and the incidence of serious ophthalmic adverse events.

Secondary Outcome Measures

Name	Time	Method
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group	Baseline to 12 months