A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 inexpensive and readily available broad-spectrum antimicrobial agent, may be an effective and affordable treatment for corneal ulcers, allowing preservation of sight for those afflicted with this disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Joseph Eye Hospital; Kolokotrones Family Foundation; L.V. Prasad Eye Institute; Research to Prevent Blindness; Thrasher Research Fund; University of California, Los Angeles; University of the Philippines
• Treatments: Cadexomer iodine; Iodine; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.