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