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Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer

NCT00557362 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-07

Study results available
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Summary

We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.

Conditions

  • Fungal Keratitis

Interventions

DRUG

Natamycin 5%

One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

DRUG

Voriconazole

Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution. One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

PROCEDURE

Corneal de-epithelialization

Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Sponsors & Collaborators

  • That Man May See, Inc.

    collaborator OTHER

  • Aravind Eye Hospitals, India

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Thomas M Lietman, MD · Proctor Foundation, University of California, San Francisco

  • Nisha Acharya, MD MS · Proctor Foundation, University of California, San Francisco

  • N V Prajna, MD · Aravind Eye Hospital, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557362 on ClinicalTrials.gov