The study was aimed to evaluate the pharmacological effect of different α-antagonists on phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for Intraoperative floppy iris syndrome (IFIS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
Sum of changes from baseline in the mean pupil diameters
Time frame: Baseline, 60 and 80 min after administration of phenylephrine (PE)
Change from baseline in mean diameter of both pupils
Time frame: Baseline, 60 and 80 min after administration of phenylephrine (PE)
Change from baseline in mean diameter of both pupils
Time frame: one week after cessation of drug
Concentration of the analyte in plasma
Time frame: Up to 29 days after first administration of α-antagonists
Number of participants with clinically significant changes in vital signs
Time frame: Up to 8 days after last pupillometry
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 8 days after last pupillometry
Number of participants with Adverse Events
Time frame: Up to 8 days after last pupillometry
Assessement of global tolerability by investigator on a 4 point scale
Time frame: 8 days after last pupillometry
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