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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
  1. Isabelle Cochereau1,
  2. Amel Meddeb-Ouertani2,
  3. Moncef Khairallah3,
  4. Abdelouahed Amraoui4,
  5. Khalid Zaghloul4,
  6. Mihai Pop5,
  7. Laurent Delval6,
  8. Pascale Pouliquen6,
  9. Radhika Tandon7,
  10. Prashant Garg8,
  11. Pablo Goldschmidt9,
  12. Tristan Bourcier9
  1. 1Service d’Ophtalmologie, CHU d’Angers, Angers, France
  2. 2Hôpital Charles NICOLLE, Tunis, Tunisia
  3. 3Service d’Ophtalmologie, Hôpital Fattouma Bourguiba, MONASTIR, Tunisia
  4. 4Hôpital du 20 Août 1953, Casablanca, Morocco
  5. 5Spitalul Clinic de Urgenta Oftalmologie, Bucharest, Romania
  6. 6Laboratoires Théa, Clermont-Ferrand, France
  7. 7RP Centre for Ophthalmic Sciences, Delhi, India
  8. 8LV. Prasad Eye Institute, Hyderabad, India
  9. 9CNO des XV-XX, Paris, France
  1. Correspondence to: I Cochereau Service d’Ophtalmologie, CHU d’Angers, 4, rue Larrey, 49033 Angers, France; iscochereau{at}


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.

  • MITT, modified-intent-to-treat
  • TOC, test-of-cure

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  • Published Online First 18 October 2006

  • This clinical trial was funded by Laboratoires Théa, Clermont-Ferrand, France.

  • Competing interests: IC, AMO, MK, AA, KZ, MP, RT, PG, PG and TB have no financial interest in Laboratoires Théa and the product A. PP and LD are employees of Laboratoires Théa.

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