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

AbstractPURPOSE:
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.
AuthorsK Kernt, M A Martinez, D Bertin, D Stroman, G Cupp, C Martínez, M Tirado, J Guasch, International Tobrex2x Group (Eu)
JournalEuropean journal of ophthalmology (Eur J Ophthalmol) 2005 Sep-Oct Vol. 15 Issue 5 Pg. 541-9 ISSN: 1120-6721 [Print] United States
PMID16167284 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anti-Bacterial Agents
  • Ophthalmic Solutions
  • Tobramycin
Topics
  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents (administration & dosage, adverse effects, chemistry)
  • Bacteria (drug effects, isolation & purification)
  • Chemistry, Pharmaceutical
  • Child
  • Child, Preschool
  • Conjunctivitis, Bacterial (drug therapy, microbiology)
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Ophthalmic Solutions (administration & dosage, adverse effects, chemistry)
  • Tobramycin (administration & dosage, adverse effects, chemistry)
  • Treatment Outcome
  • Viscosity

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