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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02266537
- Lead Sponsor
- Boehringer Ingelheim
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 97
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 exclusion criteria are of special interest for this study:
-
Hypersensitivity to any alpha agonist, or to phenylephrine
-
Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
-
Ophthalmological criteria:
- Corrected visual acuity < 0.5
- Refractive Error with a spherical equivalent > +6 or smaller - 6 D
- Elevated intraocular pressure (higher than 22 mmHg)
- Relevant anisocoria or pupil deformation
- History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery
- Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Tamsulosin Tamsulosin - Alfuzosin Alfuzosin - Doxazosin Doxazosin -
- Primary Outcome Measures
Name Time Method Sum of changes from baseline in the mean pupil diameters Baseline, 60 and 80 min after administration of phenylephrine (PE)
- Secondary Outcome Measures
Name Time Method Change from baseline in mean diameter of both pupils one week after cessation of drug 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 Number of participants with abnormal changes in clinical laboratory parameters Up to 8 days after last pupillometry 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