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

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ClinicalTrials.gov Identifier: NCT00386958
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : August 23, 2016
Sponsor:
Collaborators:
Thrasher Research Fund
Research to Prevent Blindness
University of California, Los Angeles
Kolokotrones Family Foundation
University of the Philippines
L.V. Prasad Eye Institute
Joseph Eye Hospital
Information provided by:
Los Angeles Biomedical Research Institute

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 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 or disease Intervention/treatment Phase
Infected Corneal Ulcers Bacterial Keratitis Corneal Ulcer Childhood Blindness Drug: Povidone-Iodine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers
Study Start Date : November 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

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


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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386958


Locations
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Thrasher Research Fund
Research to Prevent Blindness
University of California, Los Angeles
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

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
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: October 2006

Keywords provided by Los Angeles Biomedical Research Institute:
corneal ulcers
bacterial keratitis
childhood blindness
povidone-iodine

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