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 21, 2014
Last verified: August 2014
  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: 30
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: August 4, 2014
Last Updated: August 21, 2014
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
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 14, 2014