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 inOphthalmologica (Basel) Vol. 213; no. 4; pp. 250 - 257
Main Authors Gallenga, P.E., Lobefalo, L., Colangelo, L., Della Loggia, G., Orzalesi, N., Velati, P., Bujtar, E., Ponte, F., Damiani, S., Bucci, M.G., Bonini, S., Curatola, M.R., Palma, L.A., Bonomi, L., Tomazzoli Gerosa, L., Pagliarusco, A., Milan, E., Jauch, A.
Format Journal Article
LanguageEnglish
Published 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.
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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Cites_doi 10.1016/0732-8893(88)90094-6
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Issue 4
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
License Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
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S. Karger AG
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References Yakota T, Suzuki E, Arai K: NY-198, a novel new quinolone: Its in vitro antibacterial activity, cytotoxicity for mammalian cells, and synergy of bactericidal activity with mouse-cultured macrophages. Chemotherapy (Tokyo) 1988;36:25-35.
Malminiemi K, Karl O, Latvala ML, Voutilainen R, Miettinen A, Jauch A: Topical lomefloxacin twice daily compared with fusidic acid in bacterial conjunctivitis. Acta Ophthalmol 1995;74:114-117.
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Hatano H, Inoue K, Shia S, Wang L: Application of topical lomefloxacin against experimental Pseudomonas endophthalmitis in rabbits. Acta Ophthalmol 1993;71:666-670.8109214
Malet F, Colin J, Jauch A, Abalain ML: Bacterial keratitis therapy in guinea pigs with lomefloxacin by initially high followed by low-dosage regimen. Ophthalmic Res 1995;27:322-329.8927304
Uchida Y: Evaluation of lomefloxacin (NY-198) ophthalmic solution: A multicenter phase two double blind clinical trial. Jpn Rev Ophthalmol 1990;84:51-58.
Uchida Y: Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye: A multicenter double blind phase III study. Folia Ophthalmol Jpn 1991;42:59-70.
Elena PP, Jauch A: Ocular distribution of lomefloxacin 0.3% after a single instillation in the infected eye of pigmented rabbits. J Ocul Pharmacol Ther 1997;13:551-558.9436158
Miyao M, Tazawa H, Motoyama M, Suzuki A, Ooishi M: Intraocular penetration of current antibiotics. Acta Soc Ophthalmol Jpn 1993;97:318-323.
Ooishi M, Oornomo A, Sakaue F, Tagawa H, Miyao M, Kuriyama Y, Ikerjiri Y, Sarnejma S: Studies on intraocular penetration of NY-198 eye drops. Acta Soc Ophthalmol Jpn 1988;92:1825-1832.
Wadworth AN, Goa KL: Lomefloxacin - A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs (Adis Int) 1991;42:1018-1060.
Huguet P: Clinical study with lomefloxacin 0.3% eye drops (DR1303) in comparison with ofloxacin 0.3% eye drops (Tarivid) in the treatment of acute bacterial conjunctivitis. Abstr Proc 9th Congr Eur Soc Ophthalmol (SOE 92), Brussel, May 1992, p 163.
Ficker L, Kirkness C, McCartney A, Seal D: Microbial keratitis - The false negative. Eye 1991;51:549-559.
Richman J, Zolezio H, Tang-Liu H: Comparison of ofloxacin, gentamicin and tobramycin concentrations in tears and in vitro MICs for 90% of test organisms. Antimicrob Agents Chemother 1990;34:1602-1604.2221871
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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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