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Titolo:
DOUBLE-MASKED STUDY ON 3 PARALLEL GROUPS OF 2 0.1-PERCENT INDOMETHACIN FORMULATIONS AND 0.1-PERCENT DICLOFENAC IN THE PREVENTION AND CONTROL OF INFLAMMATION SECONDARY TO CATARACT-SURGERY
Autore:
ARNAUD B; TRINQUAND C; BRON A; DUPEYRON G; GASTAUD P; GRANGE JD; LEREBELLER MJ; LIGEON P; MATHIS A; METGE P; MISSOTTEN L; MOUILLON M; OHRLOFF C; QUEGUINER P; RIDINGS B;
Indirizzi:
HOP GUI DE CHAULIAC,SERV OPHTALMOL MONTPELLIER FRANCE
Titolo Testata:
Journal francais d'ophtalmologie
fascicolo: 3, volume: 20, anno: 1997,
pagine: 183 - 188
SICI:
0181-5512(1997)20:3<183:DSO3PG>2.0.ZU;2-O
Fonte:
ISI
Lingua:
FRE
Soggetto:
TOPICAL INDOMETHACIN; PLACEBO;
Keywords:
CATARACT SURGERY; ANTIINFLAMMATORY AGENTS; INDOMETHACIN;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
14
Recensione:
Indirizzi per estratti:
Citazione:
B. Arnaud et al., "DOUBLE-MASKED STUDY ON 3 PARALLEL GROUPS OF 2 0.1-PERCENT INDOMETHACIN FORMULATIONS AND 0.1-PERCENT DICLOFENAC IN THE PREVENTION AND CONTROL OF INFLAMMATION SECONDARY TO CATARACT-SURGERY", Journal francais d'ophtalmologie, 20(3), 1997, pp. 183-188

Abstract

Purpose To evaluate the efficiency and safety of LCM 1110 eyedrops, anew 0.1 % indomethacin formulation compared with the registered 0.1 %indomethacin solution and with 0.1 % diclofenac, in the management ofpost cataract surgery inflammation. Methods A total of 352 patients randomly assigned to LCM 1110 (n = 116), to indomethacin (n = 121) or to diclofenac (n = 115) were included in this three-arm, prospective, multicenter and double-masked trial, after giving written informed consent. They were given preoperatively I drop QID the day before surgery,5 drops within 2 hours prior to operation then 1 drop QID for 1 month. Cataracts were extracted by either extracapsular or phacoemulsification methods, With PC-IOL implantation. The main efficacy evaluation was based on the assessments of anterior chamber cells and flare at days1, 7 and 30 following surgery. Symptoms, other objective signs and IOP were recorded. Results Cellular and proteinic Tyndall phenomenon didnot significantly differ in the 3 groups, at arty of the post surgical assessments. Clinical symptoms and visual acuity improved similarly. IOP was not adversely affected by any drug. Compared with subjects having received LCM 1110, diclofenac-treated patients experienced a superficial punctuate keratitis more frequently. Tolerance of instillation, measured by a visual analogic scale, was best improved by LCM 1110 followed by the indomethacin solution and by diclofenac (LCM 1110 - diclofenac; p = 0.004). Conclusion These data suggest that LCM 1110, a new 0.1 % indomethacin ophthalmic solution, appears to be a safe promising agent for the control of postoperative inflammation.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 03/12/20 alle ore 15:51:16