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Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

NCT01344187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

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

  • Keratoconus

Interventions

DRUG

riboflavin solution

0.12% riboflavin ophthalmic solution

DRUG

placebo solution

0.0% riboflavin ophthalmic solution

DEVICE

KXL System

30 mW/cm2

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
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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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 NCT01344187 on ClinicalTrials.gov