A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine
This study has been terminated.
(Terminated- The Data Safety Monitoring Committee decided that it appeared futile to attempt to demonstrate non-inferiority of povidone-iodine to Natamycin.)
Sponsor:
University of California, Los Angeles
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: January 14, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
MedlinePlus related topics:
Molds
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | February 2013 |
| 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:
- Be more than 1 month old.
- 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.
It is acceptable to enroll a subject who has received a graft, provided the graft meets the following requirements:
- The central ulcer is well within the donor cornea.
- There is no suture abscess.
- The graft has not previously failed.
- 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:
- The initial culture fails to show the presence of fungi.
- The patient has a history of allergy to povidone-iodine, iodine, or natamycin.
- The cornea or sclera has been perforated or perforation is impending.
- The unaffected eye is legally blind.
- Dacrocystitis is present.
- Neurotrophic keratitis, exposure keratitis or keratitis sicca is present.
- Prescribed topical or systemic steroids or other immunosuppressants are being used, unless discontinued before randomization.
- The patient is known to be HIV positive.
- The infiltrate extends into the posterior one-third of the stroma.
- The initial culture shows significant growth of bacteria (>10 colonies).
- Any topical antifungal agent has been used within the past week.
- Both eyes are infected.
Contacts and Locations 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: | January 14, 2013 |
| 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:
|
Corneal Ulcer Keratitis Ulcer Eye Infections Infection Corneal Diseases Eye Diseases Pathologic Processes Povidone Iodine Cadexomer iodine Natamycin 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 Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013