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

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Research to Prevent Blindness
Kolokotrones Family Foundation
University of the Philippines
L.V. Prasad Eye Institute
Joseph Eye Hospital
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00386958
First received: October 11, 2006
Last updated: January 12, 2010
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Infected Corneal Ulcers
Bacterial Keratitis
Corneal Ulcer
Childhood Blindness
 Drug: Povidone-Iodine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Days to cure, with corneal epithelial defect closed, and no inflammatory signs other than minimal injection.
  • Safety of study medication use compared to control medications. No untoward reactions or loss of visual acuity (VA) compared with pre-treatment VA findings.

Estimated Enrollment: 172
Study Start Date: November 2002
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386958

Locations
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
University of California, Los Angeles
Thrasher Research Fund
Research to Prevent Blindness
Kolokotrones Family Foundation
University of the Philippines
L.V. Prasad Eye Institute
Joseph Eye Hospital
Investigators
Principal Investigator: Sherwin J. Isenberg, M.D. Jules Stein Eye Institute and Harbor-UCLA Medical Center
  More Information

Publications:

Responsible Party: Sherwin Isenberg, M.D., Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT00386958     History of Changes
Other Study ID Numbers: 010274-01-00R, 10274-02
Study First Received: October 11, 2006
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
corneal ulcers
bacterial keratitis
childhood blindness
povidone-iodine

Additional relevant MeSH terms:
Corneal Ulcer
Keratitis
Ulcer
Blindness
Eye Infections
Infection
Corneal Diseases
Eye Diseases
Pathologic Processes
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Povidone
 Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013