A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine

This study has been terminated.
(The DSMC decided that it appeared futile to attempt to demonstrate non-inferiority of povidone-iodine to Natamycin.)
Sponsor:
Collaborator:
Los Angeles Biomedical Research Institute
Information provided by (Responsible Party):
Sherwin J. Isenberg, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00516399
First received: August 14, 2007
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the effectiveness of 1.25% povidone-iodine ophthalmic solution for the treatment of small to medium sized fungal corneal ulcers compared with an antifungal antibiotic.


Condition Intervention Phase
Fungal Keratitis
Infected Corneal Ulcers
Drug: povidone-iodine 1.25% ophthalmic solution
Drug: natamycin ophthalmic suspension, USP 5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of days until disappearance of hypopyon and criteria for recovery and cure are met and subject is discharged home. Number of treatment failures. Ocular complications from the infection and ocular and systemic complications from the treatment. [ Time Frame: Inferior outcome is defined as cure time under povidone-iodine treatment, which is at least 4 days longer than cure time under natamycin, or time until criteria for improvement to hospital discharge is reached. ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I:
povidone-iodine 1.25% ophthalmic solution. The associated intervention descriptions contain sufficient information to describe the arm.
Drug: povidone-iodine 1.25% ophthalmic solution
Other Name: Betadine, Purdue Frederick, Norwalk
Active Comparator: II
natamycin ophthalmic suspension, USP 5%. The associated intervention descriptions contain sufficient information to describe the arm.
Drug: natamycin ophthalmic suspension, USP 5%
Other Name: Natamet, M.J. Pharmaceuticals Ltd., Mumbai, India

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be more than 1 month old.
  2. Have a history of culture positive fungal corneal ulcer, that began within 14 days of presentation to the study center characterized by either a stromal defect with infiltrate or exudate, or a positive fungal stain on smear. Other clinical criteria to suspect fungal ulcers include firm (sometimes dry) elevated slough, "hyphate" lines extending beyond the ulcer edge into normal cornea, endothelial plaque, history of organic material striking the eye, intense inflammation of the cornea and anterior chamber, immune ring, Descemet's folds, multifocal granular (or feathery) grey-white satellite stromal infiltrates. A hypopyon may be present. The diameter of the ulcer will be between 1 mm and 6 mm, as long as there is no scleral involvement.
  3. It is acceptable to enroll a subject who has received a graft, provided the graft meets the following requirements:

    1. The central ulcer is well within the donor cornea.
    2. There is no suture abscess.
    3. The graft has not previously failed.
  4. The subject should not have a foreign body present on or in the cornea or eye. A subject can be enrolled after the foreign body is totally removed and the other enrollment criteria are met.

Exclusion Criteria:

  1. The initial culture fails to show the presence of fungi.
  2. The patient has a history of allergy to povidone-iodine, iodine, or natamycin.
  3. The cornea or sclera has been perforated or perforation is impending.
  4. The unaffected eye is legally blind.
  5. Dacrocystitis is present.
  6. Neurotrophic keratitis, exposure keratitis or keratitis sicca is present.
  7. Prescribed topical or systemic steroids or other immunosuppressants are being used, unless discontinued before randomization.
  8. The patient is known to be HIV positive.
  9. The infiltrate extends into the posterior one-third of the stroma.
  10. The initial culture shows significant growth of bacteria (>10 colonies).
  11. Any topical antifungal agent has been used within the past week.
  12. Both eyes are infected.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516399

Sponsors and Collaborators
University of California, Los Angeles
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Sherwin J. Isenberg, M.D. Los Angeles Biomedical Research Institute
  More Information

No publications provided

Responsible Party: Sherwin J. Isenberg, Chief, Division of Ophthalmology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00516399     History of Changes
Other Study ID Numbers: 012488-01-00
Study First Received: August 14, 2007
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Keratitis
Ulcer
Corneal Ulcer
Pathologic Processes
Corneal Diseases
Eye Diseases
Eye Infections
Infection
Ophthalmic Solutions
Iodine
Cadexomer iodine
Povidone-Iodine
Natamycin
Povidone
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014