CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,452 enrolled
Drug / intervention
azithromycin +1 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/NCT00347776
NCT00347776Phase 4Completed

Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)

Johns Hopkins University·interventional·Posted Jul 4, 2006·Updated Aug 7, 2017

In Brief

A Phase 4 clinical trial evaluating azithromycin and topical tetracycline for Trichiasis. Completed, enrolled 1,452 participants across 1 site.

Detailed Summary

Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrichiasis
CountriesUnited States

Timeline

Phase 4CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2006
Enrollment StartAug 1, 2001
Primary CompletionDec 1, 2003
Study CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.0 years ago

Interventions

azithromycindrug

oral antibiotic

topical tetracyclinedrug