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

Overview

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)

Full Title of Study: “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 Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: February 2006

Interventions

  • Drug: Tamsulosin
  • Drug: Alfuzosin
  • Drug: Doxazosin
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Tamsulosin
  • Experimental: Alfuzosin
  • Experimental: Doxazosin
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 21 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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