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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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 Corne

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 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.
Sponsor: Avedro, Inc.

Current Primary Outcome:

  • Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group [ Time Frame: Baseline to 6 months ]
  • Safety [ Time Frame: 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.


Original Primary Outcome: Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group [ Time Frame: Baseline to 6 months ]

Current Secondary Outcome: Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group [ Time Frame: Baseline to 12 months ]

Original Secondary Outcome: Same as current

Information By: Avedro, Inc.

Dates:
Date Received: July 16, 2012
Date Started: July 2012
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017