Trials Sponsors Conditions Drugs Pricing

Conditions

Fungal Keratitis

Keywords

Fungal keratitispovidone iodinechildhood blindnesspovidone-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 solutionDrug

Also known as: Betadine, Purdue Frederick, Norwalk

natamycin ophthalmic suspension, USP 5%Drug

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

Eligibility Criteria

Age1 Month+

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Othercollaborator
University of California, Los Angeles
Otherlead

MeSH Terms

Interventions

Povidone-IodineOphthalmic Solutions

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-Ring

Study Officials

Sherwin J. Isenberg, M.D.
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

78 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

I:

II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

I:

II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record