Healthy
Conditions
Brief summary
Safety and tolerability after ocular administration
Interventions
DRUG0.02 mcg tiotropium solution
DRUG0.04 mcg tiotropium solution
DRUG0.08 mcg tiotropium solution
DRUG0.16 mcg tiotropium solution
DRUG0.28 mcg tiotropium solution
DRUG0.40 mcg tiotropium solution
DRUGPlacebo solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males * Age range from 21 to 50 years * Within ± 20% of normal weight (Broca-Index) * Written informed consent given
Exclusion criteria
* Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values * Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders * Volunteers with known history of orthostatic hypotension, fainting spells or blackouts * Volunteers with chronic or relevant acute infections * Volunteers with history of allergy/ hypersensitivity (including drug allergy) * Volunteers with known eye diseases (incl. glaucoma), with hyperopia (\> 3 diopters) or with contact lenses * Volunteers with intraocular pressure \> 22 mmHg * Volunteers with predisposition to narrow-angle glaucoma * Volunteers with disturbed micturition * Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study * Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study * Volunteers who have participated in another study with an investigational drug within the last two months preceding this study * Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Volunteers who are not able to refrain from smoking on study day * Volunteers who drink more than 40 g of alcohol per day * Volunteers who are dependent on drugs * Volunteers who have donated blood (≥ 100 ml) within the last four weeks * Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pupil diameter | baseline, after 24 hours |
| Change in pupillary reflex | baseline, after 24 hours |
| Change in intraocular pressure | baseline, after 24 hours |
| Change in accommodation | baseline, after 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in blood pressure | on Day 1 before and 24 hours after treatment and within 8 days after treatment day |
| Occurrence of Adverse Events | until 8 days after treatment day |
| Change from baseline in pulse rate | on Day 1 before and 24 hours after treatment and within 8 days after treatment day |
| Change in 12-lead ECG | on Day 1 before and 24 hours after treatment and within 8 days after treatment day |
| Changes from baseline in standard laboratory examinations | Baseline and within 8 days after treatment day |
Outcome results
None listed