3-day treatment with Azithromycin 1.5% eye-drops (Azyter(R)) versus 7-day treatment with Tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children.

Author(s): Cochereau I, Meddeb-Ouertani A, Khairallah M, Amraoui A, Zaghloul K, Pop M, Delval L, Pouliquen P, Tandon R, Garg P, Goldschmidt P, Bourcier T

Affiliation(s): CHU d'Angers, France.

Publication date & source: 2006-10-18, Br J Ophthalmol., [Epub ahead of print]

Publication type:

AIM: To compare efficacy and safety of azithromycin 1.5% eye-drops for 3 days (AZYTER(R)) with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis. METHODS: This multi-centre, randomised, investigator-masked study including 1,043 children and adults with purulent bacterial conjunctivitis compared the efficacy of azithromycin 1.5% twice-daily for 3 days versus tobramycin 0.3%, 1 drop every two hours for 2 days, then four times daily for 5 days. Signs were evaluated and cultures obtained at D0, D3 and D9. Primary variable was the clinical cure at the Test-of- Cure (TOC)-visit (D9+/-1), for patients with D0 positive cultures. The cure was defined as: bulbar conjunctival injection and discharge scored 0. RESULTS: Among 471 patients with D0-positivity in the Per Protocol set, 87.8% for azithromycin and 89.4% for tobramycin were clinically cured at the TOC-visit. Azithromycin was non-inferior to tobramycin for clinical and bacteriological cure. Clinical cure was significantly higher with azithromycin at D3. Azithromycin safety profile was satisfactory with a good patient and investigator's acceptability. CONCLUSIONS: Azithromycin 1.5% for 3 days was as effective and as safe as tobramycin for 7 days. Moreover, in azithromycin group, more patients had an early clinical cure than tobramycin at Day 3. Due to its BID dosing regimen for 3 days, it will represent an advance in the management of purulent bacterial conjunctivitis, especially in children.