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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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02266537
Collaborator
(none)
97
Enrollment
4
Arms

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Feb 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tamsulosin

Drug: Tamsulosin
Other Names:
  • Alna®

    		•
    Experimental: Alfuzosin

    Drug: Alfuzosin
    Other Names:
  • Uroxatral® uno

    		•
    Experimental: Doxazosin

    Drug: Doxazosin
    Other Names:
  • Cardular PP Uro®

    		•
    Placebo Comparator: Placebo

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Sum of changes from baseline in the mean pupil diameters [Baseline, 60 and 80 min after administration of phenylephrine (PE)]

    Secondary Outcome Measures

    1. Change from baseline in mean diameter of both pupils [Baseline, 60 and 80 min after administration of phenylephrine (PE)]

    2. Change from baseline in mean diameter of both pupils [one week after cessation of drug]

    3. Concentration of the analyte in plasma [Up to 29 days after first administration of α-antagonists]

    4. Number of participants with clinically significant changes in vital signs [Up to 8 days after last pupillometry]

    5. Number of participants with abnormal changes in clinical laboratory parameters [Up to 8 days after last pupillometry]

    6. Number of participants with Adverse Events [Up to 8 days after last pupillometry]

    7. Assessement of global tolerability by investigator on a 4 point scale [8 days after last pupillometry]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts 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 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT02266537
    Other Study ID Numbers:
    • 527.70
    First Posted:
    Oct 17, 2014
    Last Update Posted:
    Oct 17, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Mydriasis
    Doxazosin
    Tamsulosin
    Alfuzosin

    Study Results

    No Results Posted as of Oct 17, 2014