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

NCT01643252 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-04-26

No results posted yet for this study

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.

Conditions

  • Corneal Ectasia

Interventions

DRUG

riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system

Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes

DRUG

placebo: 0.0% riboflavin ophthalmic solution with the KXL system

Subjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Vineeta Belanger · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643252 on ClinicalTrials.gov