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

History of Changes

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:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Riboflavin

U.S. FDA Resources

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:

Price Vision Group website This link exits the ClinicalTrials.gov site

Publications:

Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.

Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698.


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:


Keratitis Corneal Diseases Eye Diseases Riboflavin Dermatologic Agents Growth Substances Micronutrients	Pharmacologic Actions Photosensitizing Agents Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on March 03, 2015

To Top