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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Alfuzosin; Doxazosin; Oxymetazoline; Phenylephrine; Tamsulosin

Criteria

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