Healthy
Conditions
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)
Interventions
DRUGTamsulosin
DRUGAlfuzosin
DRUGDoxazosin
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male * Age ≥ 21 and ≤ 55 years * Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 * Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study * Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on in-house trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (≥ 100 mL within four weeks prior to administration or during the trial) * Any laboratory value outside the clinically accepted reference range * Excessive physical activities within the last week before the trial or during the trial The following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of changes from baseline in the mean pupil diameters | Baseline, 60 and 80 min after administration of phenylephrine (PE) |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of the analyte in plasma | Up to 29 days after first administration of α-antagonists |
| Number of participants with clinically significant changes in vital signs | Up to 8 days after last pupillometry |
| Change from baseline in mean diameter of both pupils | Baseline, 60 and 80 min after administration of phenylephrine (PE) |
| Number of participants with Adverse Events | Up to 8 days after last pupillometry |
| Assessement of global tolerability by investigator on a 4 point scale | 8 days after last pupillometry |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to 8 days after last pupillometry |
Outcome results
None listed