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Mycotic Ulcer Treatment Trial I

NCT00996736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2018-08-01

Study results available
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Summary

The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

Conditions

  • Corneal Ulcer
  • Eye Infections, Fungal

Interventions

DRUG

Natamycin

5% natamycin plus 0.02% preservative, one drop to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until 3 weeks after enrollment.

DRUG

Voriconazole

1% voriconazole plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.

Sponsors & Collaborators

  • Aravind Eye Hospitals, India

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • National Eye Institute (NEI)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • NV Prajna, DNB, FRC Ophth · Aravind Eye Hospitals

  • Nisha Acharya, MD, MS · Proctor Foundation, UCSF

  • Tom Lietman, MD · Proctor Foundation, UCSF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • India

Study Locations

More Related Trials

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 NCT00996736 on ClinicalTrials.gov