CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 500 enrolled
Drug / intervention
Antibiotics +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00324168
NCT00324168Phase 4Completed
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Steroids for Corneal Ulcers Trial

Thomas M. Lietman·interventional·Posted May 10, 2006·Updated Aug 1, 2018

In Brief

A Phase 4 clinical trial evaluating Antibiotics, Topical corticosteroid, and 1 other intervention for Corneal Ulcer and Eye Infections, Bacterial. Completed, enrolled 500 participants across 5 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Ulcer, Eye Infections, Bacterial
CountriesIndia, United States
CollaboratorsAravind Eye Hospitals, India, Dartmouth-Hitchcock Medical Center, National Eye Institute (NEI)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 10, 2006
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.1 years ago

Interventions

Antibioticsdrug

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

Topical corticosteroiddrug

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

Placebodrug

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