Status:
COMPLETED
Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.
Eligibility Criteria
Inclusion
- Healthy subjects (volunteers) with normal twilight and night vision
- Age 18+, young and collaborative men or women
- Having given their written informed consent
- Full visual acuity (vision 0.8 or better) according to DIN Standard condition
- Refraction ≤ +/-10.0 in the highest main step
- Normal intraocular pressure (10-20 mmHg)
Exclusion
- Diabetes mellitus
- Epilepsy
- Abnormal visual acuity or abnormal morphological eye findings
- Glaucoma and macula degeneration
- Disease of the retina
- Consumption of anthocyan preparations during the past six months
- Opthalmologic pathology: cataract, visus \< 0.8, retinal pathology, maculopathy, intraocular pressure \> 21 mmHg, known acute or chronic eye disease, use of hard contact lenses, eye surgery performed within the last 12 months
- Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus, anamnestic indications of diabetic microangiopathy or polyneuropathy, renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension \> 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino
- Any treatment that might interfere with the evaluation of the test drug, in particular drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis, ethambutol, chlorpromazine, benzodiazepines or phenothiazine derivatives such as thioridazine, periciazine, perphenazine)
- Known hypersensitivity to any of the ingredients of the study drug
- Drug and alcohol abuse
- Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
- Participation in another trial within the past 30 days
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT02194361
Start Date
December 1 1999
Last Update
July 18 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.