Cross Linking for Treatment of Corneal Infection

October 19, 2017 updated by: Price Vision Group

A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis

This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of infectious keratitis

Exclusion Criteria:

  • corneal ulcer that has perforated
  • corneal ulcer that has produced a descemetocele
  • women who are pregnant or breastfeeding
  • patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 30 minute light duration
30 minute treatment with UVX light
Drug: riboflavin
riboflavin 0.1% is applied every 2 minutes for 30 minutes
Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Active Comparator: 45 minute light duration
45 minute treatment with UVX light
Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Re-epithelialization
Time Frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete
Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Resolution of Stromal Infiltration
Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved
day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

Investigators

  • Principal Investigator: Francis W Price, MD, Price Vision Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 30, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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