Clinical Trial: Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Parallel Group Study With Three Different α-antagonists and Placebo Once Daily Over Three Weeks to Assess Their Influence on the Extent of Weekly Phenylephrine-induced Myd

Brief Summary: 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)

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Sum of changes from baseline in the mean pupil diameters [ Time Frame: Baseline, 60 and 80 min after administration of phenylephrine (PE) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: October 16, 2014
Date Started: November 2005
Date Completion:
Last Updated: October 16, 2014
Last Verified: October 2014