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Kernt K, Martinez MA, Bertin D, et al. A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis. Eur J Ophthalmol. 2005;15(5):541-549doi: 10.5301/EJO.2008.993.
Kernt, K., Martinez, M. A., Bertin, D., International Tobrex X Group Eu, G., Stroman, D., Cupp, G., Martinez, C., Tirado, M., & Guasch, J. (2005). A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis. European journal of ophthalmology, 15(5), 541-549. https://doi.org/10.5301/EJO.2008.993
Kernt, K, et al. "A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis." European journal of ophthalmology vol. 15,5 (2005): 541-549. doi: https://doi.org/10.5301/EJO.2008.993
Kernt K, Martinez MA, Bertin D, International Tobrex X Group Eu G, Stroman D, Cupp G, Martinez C, Tirado M, Guasch J. A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis. Eur J Ophthalmol. 2005 Sep - Oct 2005;15(5):541-549. doi: 10.5301/EJO.2008.993. PMID: 28221457.
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Eur J Ophthalmol. 2005 Sep - Oct 2005;15(5):541-549. doi: 10.5301/EJO.2008.993.

A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis.

European journal of ophthalmology

K Kernt, M A Martinez, D Bertin, Group International Tobrex X Group Eu, D Stroman, G Cupp, C Martinez, M Tirado, J Guasch

Affiliations

  1. Augenarztpraxis, Muenchen, Germany.

PMID: 28221457 DOI: 10.5301/EJO.2008.993

Abstract

PURPOSE: To compare the safety and efficacy of a new enhanced viscosity ophthalmic formulation of tobramycin, given twice daily (BID), with the existing four times daily (QID) treatment regimen in patients with acute bacterial conjunctivitis.

METHODS: This was a 12-day, multicenter, observer-masked, randomized, parallel group study. Patients received one drop of tobramycin 0.3% (3 mg/mL) enhanced viscosity ophthalmic solution BID or tobramycin 0.3% (3 mg/mL) ophthalmic solution QID in the affected eyes for 7 days. The primary efficacy variable was the percentage of patients with sustained cure/presumed bacterial eradication based on clinical judgment at the test-of-cure visit (Day 12). Pretherapy bacterial isolates were obtained and tested for susceptibility to tobramycin by determination of minimum inhibitory concentrations (MIC).

RESULTS: A total of 276 patients were enrolled in the study and 203 of these were culture positive and attended all follow-up examinations. In this group, 98% of those treated with tobramycin enhanced viscosity ophthalmic solution and 99% of those treated with tobramycin 0.3% ophthalmic solution were categorized as having sustained cure/presumed eradication at the test-of-cure visit (p=0.6037). Reported adverse events were not serious, mild to moderate in severity, and generally did not prevent continuation in the study. Several pre treatment pathogens demonstrated tobramycin resistance (MIC > 4 mg/mL). However, therapy with both treatments was effective in the majority of the cases.

CONCLUSIONS: Tobramycin enhanced viscosity ophthalmic solution is well tolerated and has equivalent efficacy to the established treatment regimen with a simplified posology. The formulation provides an alternative therapy for acute bacterial conjunctivitis that should improve patient compliance and satisfaction. (Eur J Ophthalmol 2005; 15: 5 4 1- 9 ).

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