3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. Issue 4 (18th October 2006)

• Record Type: Journal Article
• Authors: Cochereau, Isabelle; Meddeb-Ouertani, Amel; Khairallah, Moncef; Amraoui, Abdelouahed; Zaghloul, Khalid; Pop, Mihai; Delval, Laurent; Pouliquen, Pascale; Tandon, Radhika; Garg, Prashant; Goldschmidt, Pablo; Bourcier, Tristan
• Is Part Of: British journal of ophthalmology. Volume 91:Issue 4(2007)
• Page Start: 465
• Page End: 469
• Publication Date: 2006-10-18
• Subjects: MITT, modified-intent-to-treat -- TOC, test-of-cure; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjo.2006.103556
• Languages: English
• ISSNs: 0007-1161

Abstract

Abstract : Aim: To compare the efficacy and safety of Azyter, azithromycin 1.5% eye drops, for 3 days with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis. Methods: This was a multicentre, randomised, investigator-masked study including 1043 children and adults with purulent bacterial conjunctivitis. Patients received either azithromycin 1.5% twice-daily for 3 days or tobramycin 0.3%, 1 drop every two hours for 2 days, then four times daily for 5 days. Clinical signs were evaluated and cultures obtained at D0, D3 and D9 (where D refers to "day"). 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 scores of 0. Results: Among 471 patients with D0-positivity in the per protocol set, 87.8% of the azithromycin 1.5% group and 89.4% of the tobramycin group 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 1.5% at D3. The safety profile of azithromycin 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. Furthermore, more azithromycin than tobramycin patients presented an early clinical cure at Day 3. Due to its twice daily dosing regimen for 3 days, azithromycin represents a step forward in the management of purulent bacterial conjunctivitis, especially in children.