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Titolo:
Tolerability and safety of 0.1% diclofenac plus 0.3% tobramycin fixed-doseophthalmic solution: A randomized, comparative, controlled study in healthy volunteers
Autore:
Salva, P; Costa, J; Andreu, D; Notivol, R; Martinez, M;
Indirizzi:
Univol,tonoma Barcelona, Univ Hosp Germans Trias & Pujol, Dept Clin Pharmac Univ Autonoma Barcelona Barcelona Spain E-08916 Pujol, Dept Clin Pharmac UnivE-08916ma Barcelona, Univ Hosp Germans Trias & Pujol, Dept Ophthalmol,Univ Autonoma Barcelona Barcelona Spain E-08916 Pujol, Dept Ophthalmol, Alcon Cusi, Clin Sci, Barcelona, Spain Alcon Cusi Barcelona SpainAlcon Cusi, Clin Sci, Barcelona, Spain
Titolo Testata:
METHODS AND FINDINGS IN EXPERIMENTAL AND CLINICAL PHARMACOLOGY
fascicolo: 3, volume: 21, anno: 1999,
pagine: 203 - 208
SICI:
0379-0355(199904)21:3<203:TASO0D>2.0.ZU;2-6
Fonte:
ISI
Lingua:
ENG
Soggetto:
LENS IMPLANTATION; DEXAMETHASONE; INFLAMMATION; EYEDROPS; PLACEBO;
Keywords:
tobramycin; diclofenac; ophthalmic solution; tolerability;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Salva, P Univol,tonoma Barcelona, Univ Hosp Germans Trias & Pujol, Dept Clin Pharmac Univ Autonoma Barcelona Carretera Canyet S-N Barcelona Spain E-08916
Citazione:
P. Salva et al., "Tolerability and safety of 0.1% diclofenac plus 0.3% tobramycin fixed-doseophthalmic solution: A randomized, comparative, controlled study in healthy volunteers", METH FIND E, 21(3), 1999, pp. 203-208

Abstract

The purpose of this double-blind observer-masked randomized, crossover trial was to compared the tolerability and safety of a fixed-dose ophthalmic solution of 0.3% tobramycin plus 0.1% diclofenac versus Tobrex(R) (tobramycin sulfate ophth) and Voltaren(R) (diclofenac sodium). Control treatments included a saline solution and a control solution of 0.3% tobramycin preparedby Alcon Cusi. Ten healthy volunteers received three consecutive instillations of I drop of a given ophthalmic solution at 08:00, 11:00 and 14:00 h to the same eye; after a washout period of 18 h, the next ophthalmic solution was tested according to a randomized sequence. Occurrence, intensity, andduration of ocular irritation and conjunctival hyperemia at baseline and after the three instillations were recorded. Slit lamp biomicroscopy examination, measurement of intraocular pressure (IOP) changes, visual acuity, andexamination of the fundus of the eye were performed after each third instillation by an ophthalmologist. Side effect incidence and patient and investigator opinions were also recorded. Results showed that Voltaren(R) instillation induced statistically significant ocular irritation (p = 0.0077); theremaining ophthalmic solutions tested caused no ocular irritation (Physiological Saline Braun(R), p = 0.9808; Tobrex(R), p = 0.8826; control 0.3% tobramycin solution, p = 0.8327; and 0.1% diclofenac plus 0.3% tobramycin, p =0.5399). None of the ophthalmic solutions tested caused severe conjunctival hyperemia. Analysis of the sum of conjunctival parameters of both eyes for all ophthalmic solutions studied showed no statistically significant differences (p = 0.4688). Moderate superficial punctate keratitis was observed after instillation of Voltaren(R) and of 0.1% diclofenac plus 0.3% tobramycin (1 subject each) that spontaneously resolved within 2 days. Slit lamp biomicroscopy, visual acuity and IOP values showed no statistically significant changes. No systemic side effects related to the study treatments were recorded. In conclusion the ophthalmic solution containing 0.1% diclofenac pills 0.3% tobramycin was well tolerated under rite study conditions. Its tolerability was equivalent to that of Braun(R) physiological saline, Tobrex(R) and a control 0.3% tobramycin solution and was better than that of Voltaren(R). (C) 1999 Prous Science. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 13/07/20 alle ore 14:09:56