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Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

This study is currently recruiting participants.
Verified November 2012 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01739673
First received: November 27, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.


Condition Intervention
Infectious Keratitis
 Other: Ultraviolet-A and riboflavin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

Resource links provided by NLM:

Drug Information available for: Riboflavin
U.S. FDA Resources

Further study details as provided by Cxlusa:

Primary Outcome Measures:
  • Resolution of Signs and Symptoms of Infectious Keratitis [ Time Frame: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultraviolet-A and riboflavin Other: Ultraviolet-A and riboflavin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older.
  2. Ability to provide written informed consent.
  3. Likely to complete all study visits.
  4. Subjects must have one eye that with a diagnosis of infectious keratitis.

Exclusion Criteria:

  1. A corneal perforation.
  2. Descemetocele.
  3. Pregnancy or breastfeeding.
  4. Active Herpes corneal disease.
  5. Patient is unwilling or unable to comply with a medication regimen and follow up appointments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739673

Contacts
Contact: Kristin Williams kristin@lexitaspharma.com

Locations
United States, Arizona
Schwartz Laser Eye Center Recruiting
Scottsdale, Arizona, United States
United States, California
Davidorf Eye Group Recruiting
West Hills, California, United States
United States, Colorado
Corneal Consultants of Colorado, PC Recruiting
Littleton, Colorado, United States
United States, Florida
Center for Excellence in Eye Care Recruiting
Miami, Florida, United States
United States, Minnesota
Minnesota Eye Consultants Recruiting
Minneapolis, Minnesota, United States
United States, Missouri
Ophthalmology Associates Recruiting
St. Louis, Missouri, United States
Sponsors and Collaborators
Cxlusa
Investigators
Study Director: William Trattler, MD Center For Excellence In Eye Care
  More Information

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01739673     History of Changes
Other Study ID Numbers: iCXL
Study First Received: November 27, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cxlusa:
Infectious Keratitis

Additional relevant MeSH terms:
Riboflavin
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases
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 May 21, 2013