Status:
COMPLETED
Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
Brief Summary
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
Eligibility Criteria
Inclusion
- Healthy subjects (volunteers) with age-related impaired twilight and night
- Age 50 to 70, men or women
- Written informed consent
- Full visual acuity (vision ≥ 0.7) according to DIN Standard condition
- Refraction ≤ +/-6.0 in the highest main step
- Age-related findings in the ophthalmologic examination (anterior chamber and eye ground)
- Normal intraocular pressure (10-20 mmHg)
Exclusion
- Diabetes mellitus
- Epilepsy
- Abnormal visual acuity or eye ground (e.g. clouding of the lens)
- Age related vision problems
- Glaucoma and macular degeneration
- Disease of the retina
- Consumption of anthocyan preparations during the past six months
- Opthalmologic pathology: cataract, visus \< 0.7, 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 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 :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT02194127
Start Date
November 1 1998
Last Update
July 24 2014
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