Cross Linking for Treatment of Corneal Infection

This study has been terminated.
(insufficient efficacy)
Sponsor:
Collaborator:
Cornea Research Foundation of America
Information provided by (Responsible Party):
Price Vision Group
ClinicalTrials.gov Identifier:
NCT00912509
First received: May 30, 2009
Last updated: August 9, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Infectious Keratitis
Drug: riboflavin
Device: UVX Light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis

Resource links provided by NLM:


Further study details as provided by Price Vision Group:

Primary Outcome Measures:
  • time to re-epithelialization [ Time Frame: Day 1, Day 2, Day 3, (daily assessment) after study treatment until re-epithelialization is complete ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to resolution of stromal infiltration [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, week 3 (weekly assessment) until infiltrate is completely resolved ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912509

Locations
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Price Vision Group
Cornea Research Foundation of America
Investigators
Principal Investigator: Francis W Price, MD Price Vision Group
  More Information

Additional Information:
Publications:
Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT00912509     History of Changes
Other Study ID Numbers: 2008-0143
Study First Received: May 30, 2009
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Price Vision Group:
infectious keratitis
cross linking
corneal ulcer
corneal infection
collagen cross linking

Additional relevant MeSH terms:
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014