Dose-response study of dapiprazole HCl in the reversal of mydriasis induced by 2.5% phenylephrine.
J Ocul Pharmacol Ther
; 13(4): 297-302, 1997 Aug.
Article
en En
| MEDLINE
| ID: mdl-9261765
Dapiprazole HCL is currently available in the United States for reversal of diagnostic mydriasis. The recommended dosage for this indication is 2 drops followed 5 minutes later by 2 drops. We studied the dose-response profile and tolerance of three different treatment regimens: 1 drop alone, 1 drop followed by 1 additional drop 5 minutes later, and 2 drops followed by 2 additional drops 5 minutes later. Sixty normal male and female volunteers between 18 and 40 years of age were recruited for a double-masked, placebo-controlled, crossover study in which each eye of each subject was dilated with 2.5% phenylephrine. After one hour, one eye was treated with 0.5% dapiprazole, and the contralateral eye was treated with placebo. Each subject was treated with each of the three dapiprazole regimens in three different study sessions separated by at least 5 days (drug half-life in the eye is 5 hours). Analysis of AUC demonstrated no significant difference (P = 0.620) between the 1 drop regimen and the 2 + 2 regimen. A single drop of dapiprazole has a clinical effect equivalent to the 2 + 2 drop regimen in eyes dilated with 2.5% phenylephrine, which should improve the cost-effectiveness of this mydriolytic agent.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fenilefrina
/
Triazoles
/
Pupila
/
Antagonistas Adrenérgicos alfa
/
Acomodación Ocular
/
Midriáticos
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Ocul Pharmacol Ther
Asunto de la revista:
FARMACOLOGIA
/
OFTALMOLOGIA
/
TERAPEUTICA
Año:
1997
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Estados Unidos