A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine (NCT00516399) | Clinical Trial Compass
TerminatedPhase 3
A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine
Stopped: The DSMC decided it appeared futile to attempt to demonstrate non-inferiority of povidone-iodine to Natamycin.
78 participantsStarted 2008-03
Plain-language summary
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.
Who can participate
Age range1 Month
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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.
Timeframe: 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.