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Steroids for Corneal Ulcers Trial

NCT00324168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2018-08-01

Study results available
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Summary

The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

Conditions

  • Corneal Ulcer
  • Eye Infections, Bacterial

Interventions

DRUG

Antibiotics

moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization

DRUG

Topical corticosteroid

prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

DRUG

Placebo

0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

Sponsors & Collaborators

  • Aravind Eye Hospitals, India

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • National Eye Institute (NEI)

    collaborator NIH

  • Thomas M. Lietman

    lead OTHER

Principal Investigators

  • M. Srinivasan, M.S., O.D. · Aravind Eye Hospital

  • Mike Zegans, M.D. · Dartmouth-Hitchcock Medical Center

  • Nisha Acharya, M.D., M.S. · Proctor Foundation, UCSF

  • Thomas M Lietman, M.D. · 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
2006-09-30
Primary Completion
2011-02-28
Completion
2012-12-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT00324168 on ClinicalTrials.gov