Since its introduction, dapiprazole has been used in a 2+2 regimen, two drops followed by two more drops 5 minutes later. In clinical practice, returning to dose the patient for a second time in 5 minutes can sometimes be troublesome for both the ophthalmologist and the patient. After a review of the literature on dapiprazole, Doughty and Lyle2 suggested that further studies should be conducted to investigate the optimum dosing regimen. In addition, the capacity of the cul de sac has been estimated as 0-025 ml,3 suggesting that significant washout of a two drop dose may occur; furthermore, known side effects of dapiprazole may also be reduced by a regimen with fewer drops.This study explored the comparative efficacy of three regimens of dapiprazole. Regimens were compared with respect to reversal of mydriasis, improvement in accommodation, and incidence of side effects. Known eye colour effects (slower reversal of mydriasis in patients with dark irides) were controlled for in the experimental design.
STUDY OBJECTIVEThe objective of this study was to demonstrate the equivalence of two test regimens to a 'reference' regimen of 0-5% dapiprazole in their ability to reverse mydriasis induced by 2-5% phenylephrine (Neosynephrine, Winthrop) and 05% tropicamide (Bausch and Lomb). A secondary objective was to evaluate and compare the subject's ability to tolerate the three regimens. No previous study had compared the effects of different regimens of 05% dapiprazole.Materials and methods A clinically significant mean change from baseline for pupil diameter, between reference and test compounds, was 0 5 mm. Data from a previous study indicated a within (intra) subject variance of 0O81. The computed sample size was 55 subjects. In order to allocate an 544 on 10 May 2018 by guest. Protected by copyright.
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