Pharmacodynamics of IMP 08P2002F0 (Fixed dose combination of 0.34% tropicamide and 2.5% phenylephrine hydrochloride, eye drop, Solution) a new ophthalmic mydriatic solution in healthy volunteers.

to obtain pre-operative mydriasis or for diagnostic purposes

The primary endpoint is the change in pupil diameter at 60 min from the time of first dose versus baseline, as measured with pupil photographs (central reading)

Time to obtain sufficient mydriasis. (Defined as pupil diameter of 7.0 mm), Proportion of eyes achieving pupil diameter of 6.0 mm or greater throughout the 6 hours, at 30 min, at 1 h, at 2 h, Proportion of eyes achieving pupil diameter of 7.0 mm or greater throughout the 6 hours, at 30 min, at 1 h, at 2 h, Time from baseline to maximal pupil dilation, Change in pupil diameter at other timepoints (10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h), Pupil size measured at 10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h, Distribution of pupil diameters at 10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h, Subject discomfort at the following recording times: 10 min, 30 min, 60 min, 2 h, 6 h, Percent of subjects' study eyes with Pupil Diameter Returning to Baseline [Time Frame: throughout the 6 hours, at 3 h, 4 h, 5°h and 6 h], Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter [Time Frame: throughout the 6 hours, at 3 h, 4 h, 5°h and 6 h], Occurrence of Adverse events, Ocular symptoms other than mydriasis

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