Dose-response study of dapiprazole HCl in the reversal of mydriasis induced by 2.5% phenylephrine.

Abstract

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.

• Authors: T S Hogan, D D McDaniel, J D Bartlett, K K Hart, D A Paggiarino
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 13 Issue 4 Pg. 297-302 (Aug 1997) ISSN: 1080-7683 [Print] United States
• PMID: 9261765 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic alpha-Antagonists
• Mydriatics
• Ophthalmic Solutions
• Piperazines
• Triazoles
• Phenylephrine
• dapiprazole

Topics

• Accommodation, Ocular (drug effects, physiology)
• Adolescent
• Adrenergic alpha-Antagonists (administration & dosage, adverse effects)
• Adult
• Area Under Curve
• Conjunctival Diseases (chemically induced)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Hyperemia (chemically induced)
• Male
• Mydriatics (administration & dosage)
• Ophthalmic Solutions
• Phenylephrine (administration & dosage)
• Piperazines
• Pupil (drug effects, physiology)
• Triazoles (administration & dosage, adverse effects)