May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Study of Efficacy and Safety of Azithromycin T1225 1.5% in Children With Bacterial Conjunctivitis
Author Affiliations & Notes
  • D. Bremond-Gignac
    Robert Debre Hospital, APHP, Paris, France
    Department of Ophthalmology,
    INSERM UMRS 872, Paris, France
  • P. Mariani-Kurkdjian
    Robert Debre Hospital, APHP, Paris, France
    Microbiology Department,
  • A. Beresniak
    Epidemiology, LIRAES, University Paris-Descartes, Paris, France
    Epidemiology, Modelism, Data Mining International, Geneva, Switzerland
  • L. El Fekhi
    Ophthalmology, Hôpital des forces de sécurité intérieure, Tunis, Tunisia
  • Y. Baghat
    Ophthalmology, St. George’s Hospital, Mumbai, India
  • P. Pouliquen
    Laboratoires Théa, Clermont-Ferrand, France
  • L. Delval
    Laboratoires THEA, Clermont-Ferrand, France
  • P. Goldschmidt
    Department of Ophthalmology, CHNO des Quinze Vingts, Paris, France
  • E. Bingen
    Robert Debre Hospital, APHP, Paris, France
    Department of Microbiology,
  • I. Cochereau
    Department of Ophthalmology, CHU d’Angers, Angers, France
  • Footnotes
    Commercial Relationships  D. Bremond-Gignac, None; P. Mariani-Kurkdjian, None; A. Beresniak, None; L. El Fekhi, None; Y. Baghat, None; P. Pouliquen, employee of Laboratoires THEA, E; L. Delval, employee of Laboratoires THEA, E; P. Goldschmidt, None; E. Bingen, None; I. Cochereau, None.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 1978. doi:https://doi.org/
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      D. Bremond-Gignac, P. Mariani-Kurkdjian, A. Beresniak, L. El Fekhi, Y. Baghat, P. Pouliquen, L. Delval, P. Goldschmidt, E. Bingen, I. Cochereau; Study of Efficacy and Safety of Azithromycin T1225 1.5% in Children With Bacterial Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1978. doi: https://doi.org/.

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

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Abstract

Purpose: : The purpose of the study was to analyze the efficacy and safety of azithromycin 1.5% eye-drops (T1225) in the treatment of purulent bacterial conjunctivitis versus tobramycin 0.3% in a subset of 150 children. The ocular pathogens in conjunctivitis were also aimed to be studied in the population.

Methods: : This multicenter, randomized, investigator-masked, parallel-group study, included 150 newborns, children and adolescent in a large study having enrolled 1,043 patients and compared T1225 twice daily for 3 days and tobramycin 0.3% 1 drop every two hours for 2 days then four times daily for 5 days. Signs and symptoms were evaluated and cultures obtained at baseline, Days 3 and 9. Primary efficacy variable was the clinical cure (score 0 for bulbar conjunctival injection and purulent discharge) at the test of cure visit (Day 9).

Results: : In the population, 58 patients had positive cultures at Day 0. Both treatments were effective with a clinical and microbiological cure of more than 80% of children on Day 9. T1225 provided a significantly quicker cure on Day 3 than tobramycin (p<0.001). Resistant species were resolved by T1225. No adverse effects were noted on the ocular surface. The involved ocular conjunctival pathogen flora in children was analyzed and cocci species were predominant.

Conclusions: : T1225 leads to a rapid clinical cure with negative microbiological control. The spectrum of azithromycin allow to treat frequent pathogen in children. This short-treatment course can be easily used in children, thus improving the quality of life.

Clinical Trial: : www.clinicaltrials.gov NCT00357773

Keywords: anatomy • conjunctivitis • keratitis 
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