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Cross Linking for Treatment of Corneal Infection

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ClinicalTrials.gov Identifier: NCT00912509
Recruitment Status : Terminated (insufficient efficacy)
First Posted : June 3, 2009
Results First Posted : August 22, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Cornea Research Foundation of America
Information provided by (Responsible Party):
Price Vision Group

Tracking Information
First Submitted Date  ICMJE May 30, 2009
First Posted Date  ICMJE June 3, 2009
Results First Submitted Date  ICMJE August 4, 2014
Results First Posted Date  ICMJE August 22, 2014
Last Update Posted Date November 22, 2017
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2009)
Time to Re-epithelialization [ Time Frame: assessed daily until complete re-epithelialization is noted ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2009)
Time to Resolution of Stromal Infiltration [ Time Frame: assessed daily through 1 week, then weekly until resolution of infiltrate ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cross Linking for Treatment of Corneal Infection
Official Title  ICMJE A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis
Brief Summary This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infectious Keratitis
Intervention  ICMJE
  • 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%
Study Arms  ICMJE
  • Active Comparator: 30 minute light duration
    30 minute treatment with UVX light
    Interventions:
    • Drug: riboflavin
    • Device: UVX Light
  • Active Comparator: 45 minute light duration
    45 minute treatment with UVX light
    Intervention: Device: UVX Light
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2009)
200
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912509
Other Study ID Numbers  ICMJE 2008-0143
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Price Vision Group
Study Sponsor  ICMJE Price Vision Group
Collaborators  ICMJE Cornea Research Foundation of America
Investigators  ICMJE
Principal Investigator: Francis W Price, MD Price Vision Group
PRS Account Price Vision Group
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP