Topical Lomefloxacin 0.3% Twice Daily versus Tobramycin 0.3% in Acute Bacterial Conjunctivitis: A Multicenter Double-Blind Phase III Study
Aims/Background: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. Methods: Ninety-nine subjects were enrolled: 50 we...
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Published in | Ophthalmologica (Basel) Vol. 213; no. 4; pp. 250 - 257 |
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Main Authors | , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Basel, Switzerland
Karger
01.07.1999
S. Karger AG |
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Abstract | Aims/Background: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. Methods: Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed. Results: There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3–4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3–4 to day 7–8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lome-floxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%). Conclusion: Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated. |
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AbstractList | To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis.
Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed.
There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3-4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3-4 to day 7-8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lomefloxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%).
Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated. <Aims/Background:< To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. <Methods:< Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed. <Results:< There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3-4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3-4 to day 7-8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lome-floxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%). <Conclusion:< Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated. Aims/Background: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. Methods: Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed. Results: There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3–4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3–4 to day 7–8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lome-floxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%). Conclusion: Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated. AIMS/BACKGROUNDTo evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis.METHODSNinety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed.RESULTSThere was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3-4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3-4 to day 7-8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lomefloxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%).CONCLUSIONBoth lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated. |
Author | Milan, E. Orzalesi, N. Della Loggia, G. Bonomi, L. Tomazzoli Gerosa, L. Bujtar, E. Damiani, S. Lobefalo, L. Bucci, M.G. Bonini, S. Palma, L.A. Gallenga, P.E. Ponte, F. Jauch, A. Colangelo, L. Curatola, M.R. Pagliarusco, A. Velati, P. |
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Keywords | Lomefloxacin 0.3 Bacterial resistance Acute bacterial conjunctivitis Tobramycin 0.3 Human Acute Treatment efficiency Lomefloxacin Conjunctiva disease Conjunctivitis Infection Eye drop Local administration Eye disease Antibiotic Chemotherapy Fluoroquinolone derivatives Treatment Aminoglycoside Bacteriosis Tobramycin Antibacterial agent Comparative study Quinolone derivatives |
Language | English |
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SubjectTerms | Acute Disease Adolescent Adult Aged Aged, 80 and over Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - therapeutic use Anti-Infective Agents - administration & dosage Anti-Infective Agents - therapeutic use Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Bacteria Bacteria - drug effects Bacteria - growth & development Bacteria - isolation & purification Biological and medical sciences Child Colony Count, Microbial Conjunctiva - microbiology Conjunctivitis, Bacterial - drug therapy Conjunctivitis, Bacterial - microbiology Double-Blind Method Female Fluoroquinolones Follow-Up Studies Haemophilus Infections - drug therapy Haemophilus Infections - microbiology Humans Male Medical sciences Middle Aged Ophthalmic Solutions Original Paper · Travail original · Originalarbeit Pharmacology. Drug treatments Prospective Studies Quinolones - administration & dosage Quinolones - therapeutic use Staphylococcal Infections - drug therapy Staphylococcal Infections - microbiology Streptococcal Infections - drug therapy Streptococcal Infections - microbiology Tobramycin - administration & dosage Tobramycin - therapeutic use Treatment Outcome |
Title | Topical Lomefloxacin 0.3% Twice Daily versus Tobramycin 0.3% in Acute Bacterial Conjunctivitis: A Multicenter Double-Blind Phase III Study |
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