title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Service d'Ophtalmologie, CHU d'Angers, 4, rue Larrey, 49033 Angers, France. iscochereau@chu-angers.fr
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cochereau
authors.forename: Amel
authors.initials: A
authors.lastname: Meddeb-Ouertani
authors.forename: Moncef
authors.initials: M
authors.lastname: Khairallah
authors.forename: Abdelouahed
authors.initials: A
authors.lastname: Amraoui
authors.forename: Khalid
authors.initials: K
authors.lastname: Zaghloul
authors.forename: Mihai
authors.initials: M
authors.lastname: Pop
authors.forename: Laurent
authors.initials: L
authors.lastname: Delval
authors.forename: Pascale
authors.initials: P
authors.lastname: Pouliquen
authors.forename: Radhika
authors.initials: R
authors.lastname: Tandon
authors.forename: Prashant
authors.initials: P
authors.lastname: Garg
authors.forename: Pablo
authors.initials: P
authors.lastname: Goldschmidt
authors.forename: Tristan
authors.initials: T
authors.lastname: Bourcier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D016037:Single-Blind Method; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions; D017963:Azithromycin; D014031:Tobramycin