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.
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Authors | K Kernt, M A Martinez, D Bertin, D Stroman, G Cupp, C Martínez, M Tirado, J Guasch, International Tobrex2x Group (Eu) |
Journal | European journal of ophthalmology
(Eur J Ophthalmol)
2005 Sep-Oct
Vol. 15
Issue 5
Pg. 541-9
ISSN: 1120-6721 [Print] United States |
PMID | 16167284
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Ophthalmic Solutions
- Tobramycin
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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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