May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Purulent Bacterial Conjunctivitis: Bacteriological Efficacy of 3-Days 1.5% Azithromycin Dihydrate Eye Drop Solution (azith) versus 7 Days of Tobramycin (tobra) 0.3 %
Author Affiliations & Notes
  • P. Pouliquen
    Ophthalmology, Laboratoires Thea, Clermont Ferrand Cedex 2, France
  • P. Goldschmidt
    Laboratory, Laboratoire du Centre National d’Ophtalmologie des Quinze-Vingts, Paris, France
  • C. Chaumeil
    Laboratory, Laboratoire du Centre National d’Ophtalmologie des Quinze-Vingts, Clermont Ferrand Cedex 2, France
  • F. Denis
    Bacteriology, CHU de Limoges, Limoges, France
  • L. Delval
    Ophthalmology, Laboratoires Thea, Clermont Ferrand Cedex 2, France
  • J. Luyckx
    Ophthalmology, Laboratoires Thea, Clermont Ferrand Cedex 2, France
  • I. Cochereau
    Ophthalmology, CHU Angers, Angers, France
  • Footnotes
    Commercial Relationships  P. Pouliquen, yes, E; P. Goldschmidt, None; C. Chaumeil, None; F. Denis, None; L. Delval, Yes, E; J. Luyckx, Yes, E; I. Cochereau, None.
  • Footnotes
    Support  Laboratoires Thea
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 2501. doi:
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      P. Pouliquen, P. Goldschmidt, C. Chaumeil, F. Denis, L. Delval, J. Luyckx, I. Cochereau; Purulent Bacterial Conjunctivitis: Bacteriological Efficacy of 3-Days 1.5% Azithromycin Dihydrate Eye Drop Solution (azith) versus 7 Days of Tobramycin (tobra) 0.3 %. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2501.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose:
 

Assess the bacteriological efficacy of 3-days azith eye drops in comparison to tobra (reference product) for the treatment of purulent bacterial conjunctivitis.

 
Methods:
 

Multicentre, investigator-masked, randomised, non-inferiority GCP study. A total of 55 centres (France,Portugal,Bulgaria,Romania, Tunisia,Morocco,Guinea Conakry and India) included newborns, infants, childs and adults followed in 3 visits:D0,D3 and D9 (Test-of-Cure). Inclusion: male or female; ≥ 1 day old with purulent bacterial conjunctivitis (bulbar conjunctival injection and purulent discharge). Primary efficacy variable: no signs in the worse eye at D9 and no discharge. Samples were positive if bacteria were isolated above Cagle’s threshold. Resolution was defined as the absence or reduction below threshold at D9 in patients with pos D0 cultures

 
Results:
 

218 evaluable patients with pos samples at D0 were planned in each group; 1015 treated; 976 completed study (489 azith, 487 tobra). Clinical resolution: 3 days of azith (6 drops) was non-inferior to tobra (>35 drops during 7 days) for clinical and bacteriological resolution. For both products, the efficacy, safety and tolerability were good in the 150 children (< 18 years old) and adults who participated in the study.

 
Conclusions:
 

3 days treatment azith 1.5% solution shows bacteriological efficacy for the treatment of purulent bacterial conjunctivitis and compared with the reference product has the advantage of a low dosing regimen of 1 drop in each eye twice daily for 3 days.  

 
Clinical Trial:
 

www.clinicaltrials.gov NCT00357773

 
Keywords: conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • antibiotics/antifungals/antiparasitics 
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