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

• Published in: British journal of ophthalmology 2007-04, Vol.91 (4), p.465-469
• Main 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
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Azithromycin - administration & dosage; Azithromycin - adverse effects; Azithromycin - therapeutic use; Bacteria; Biological and medical sciences; Child; Child, Preschool; Clinical Science - Extended Report; Conjunctivitis, Bacterial - drug therapy; Drug Administration Schedule; Female; Humans; Infant; Infant, Newborn; Male; Medical sciences; Middle Aged; Miscellaneous; MITT; modified-intent-to-treat; Ophthalmic Solutions; Ophthalmology; Single-Blind Method; test-of-cure; Tobramycin - administration & dosage; Tobramycin - adverse effects; Tobramycin - therapeutic use; TOC; Treatment Outcome
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjo.2006.103556

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.