Status:
COMPLETED
A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
Thrasher Research Fund
Research to Prevent Blindness
Conditions:
Infected Corneal Ulcers
Bacterial Keratitis
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
Bacterial corneal ulcers are a leading cause of pediatric blindness in underdeveloped countries due to a lack of antibiotic availability and affordability, among other reasons. Povidone-iodine, an ine...
Detailed Description
Hypothesis to be tested: Infectious corneal ulceration causes corneal scarring, opacification, and blindness in hundreds of thousands of children annually. In developing countries, it is the number o...
Eligibility Criteria
Inclusion
- Clinical diagnosis of untreated bacterial corneal ulcer that began within 14 days of presentation to the study center.
- Corneal ulcer size is 2 mm-8 mm. in diameter, and does not extend to the limbus.
Exclusion
- Topical or systemic antimicrobial or immunosuppressant therapy within 14 days of presentation to the study center.
- Corneal ulcer smear and culture fail to show the presence of bacteria.
- Allergic history to povidone-iodine, iodine or any components of Neosporin.
- Dacrocystitis, neurotropic or exposure keratitis, keratitis sicca, positive HIV status, and legal blindness in the unaffected eye.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00386958
Start Date
November 1 2002
End Date
January 1 2006
Last Update
August 23 2016
Active Locations (1)
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1
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502