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Dominique Bremond-Gignac, Frederic Chiambaretta, Hachemi Nezzar, Bruno Mortemousque, Claude Speeg-Schatz, Solange Milazzo, Azithromycin Study Group; Clinical Efficacy and Safety of Azithromycin 1.5% versus Tobramycin 0.3 % Eye Drops in the Treatment of Children Bacterial Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2012;53(14):6268.
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Bacterial infection is a common cause of conjunctivitis and accounts for 70% to 80% of all cases of conjunctivitis in children. The aim of the study was to evaluate safety and efficacy of topical azithromycin 1.5% in bacterial conjunctivitis in children.
A phase III randomized masked study, approved by ethics committee, included 283 children presenting purulent bacterial conjunctivitis in 8 countries. Patients received 1 drop of azithromycin twice a day for 3 days (146 in group A) or 1 drop of tobramycin every 2 hours (up to 8 times per day) for 2 days, then 1 drop 4 times daily for 5 days (137 in group T). Ocular examinations were performed at D0, D3, D7 with conjunctival swabbing at D0 and D7. Patients range was: 148 patients (0- <2 yo), 44 patients (2- <4 yo), 77 patients (4- <12 yo) and 13 patients (12- <18 yo). Efficacy was evaluated with the clinical cure (based on bulbar conjunctival injection and conjunctival purulent discharge) on D3 for patients with D0 positive cultures. Clinical cure assessment at D7 and conjunctival swabbing at D0 and D7 was also performed. Safety data were also recorded.
Among patients with a positive culture on D0, clinical cure in the worse eye on D3 the azithromycin group 47.1% was significantly superior compared with tobramycin group 28.7% (p=0.013). At D7, azithromycin (89.2% of patients cured) was non-inferior to tobramycin (78.2% cured). The global efficacy assessed by the investigator, at D3, was rated as "very satisfactory" for 60.6% of patients group A and for 42% of patients group T (p=0.011), at D7: 76.8% for azithromycin group versus 55% for tobramycin group (p=0.003). Bacteriological resolution on Day 7 was observed for 89.8% of patients in the T1225 group and 87.2% in the Tobramycin group.Similar efficacy findings were observed in the younger subgroup (0-2yo). No significant adverse event was observed during the study and acceptability assessments by the investigator were significantly better for azithromycin than for tobramycin (p=0.013).
In the study, Azithromycin 1.5% eye drops appears non inferior to Tobramycin with a good safety profile for the treatment of purulent bacterial conjunctivitis in paediatric patients. Azithromycin therapy, with a short duration treatment twice a day, provided a significant clinical cure on D3 and leads to a better quality of life for children and parents.
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