NCT00105469

A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

Completed Phase 3 Results posted Last updated 21 November 2013

What this trial tests

Phase 3 trial testing AzaSite in Bacterial Conjunctivitis in 743 participants. Completed in 1 October 2005.

Timeline

1 July 2004

Primary endpoint
1 October 2005

1 October 2005

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	743
Start date	1 July 2004
Primary completion	1 October 2005
Estimated completion	1 October 2005
Sites	26 locations across United States

Drugs / interventions tested

• AzaSite
• Tobramycin (tobramycin) — full drug profile →

Conditions studied

• Bacterial Conjunctivitis — all drugs for Bacterial Conjunctivitis →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

1 and older, any sex, with Bacterial Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Who Achieved Clinical Resolution at Visit 3
  Time frame: Visit 3 (Day 6)
  Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).

Sponsor's own description

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis.
   Protzko E, Bowman L, Abelson M, Shapiro A, et al · · 2007 · cited 35× · PMID 17652708 · DOI 10.1167/iovs.06-1413
2. Update and critical appraisal of the use of topical azithromycin ophthalmic 1% (AzaSite) solution in the treatment of ocular infections.
   Utine CA. · · 2011 · cited 7× · PMID 21750614 · DOI 10.2147/opth.s13785