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

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: Cadexomer iodine; Iodine; Natamycin; Ophthalmic Solutions; Povidone; Povidone-Iodine

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.