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

NCT00516399 | Terminated Phase 3 DMC

• 1 other identifier: 012488-01-00
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fungal Keratitis

Keywords

Fungal keratitis; povidone iodine; childhood blindness; povidone-iodine

Outcome Measures

Primary Outcomes (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.

  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.

Study Arms (2)

I:

EXPERIMENTAL

povidone-iodine 1.25% ophthalmic solution. The associated intervention descriptions contain sufficient information to describe the arm.

Drug: povidone-iodine 1.25% ophthalmic solution

II

ACTIVE COMPARATOR

natamycin ophthalmic suspension, USP 5%. The associated intervention descriptions contain sufficient information to describe the arm.

Drug: natamycin ophthalmic suspension, USP 5%

Interventions

povidone-iodine 1.25% ophthalmic solution DRUG

Also known as: Betadine, Purdue Frederick, Norwalk

I:

natamycin ophthalmic suspension, USP 5% DRUG

Also known as: Natamet, M.J. Pharmaceuticals Ltd., Mumbai, India

II

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

MeSH Terms

Interventions

Povidone-Iodine; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Sherwin J. Isenberg, M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Ophthalmology

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: March 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 4, 2014

Record last verified: 2014-12