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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Alfuzosin; Drug: Placebo; Drug: Tamsulosin; Drug: Doxazosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02266537

527.70

Details and patient eligibility

About

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)

Enrollment: 97 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 4 patient groups, including a placebo group

Tamsulosin

Experimental group

Treatment:

Drug: Tamsulosin

Alfuzosin

Experimental group

Treatment:

Drug: Alfuzosin

Doxazosin

Experimental group

Treatment:

Drug: Doxazosin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo