Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT02266537
Start Date
November 1 2005
Last Update
October 17 2014
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