Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision

NCT02194127 | Completed Phase 2

• 1 other identifier: 1147.2
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Measurement of the maximum velocity of dilatation of the pupil

  day 29

Secondary Outcomes (16)

• Measurement of the maximum velocity of dilatation of the pupil

  Days 1 and 8

• Measurement of the initial pupil diameter

  days 1, 8 and 29

• Measurement of the latency time

  Days 1, 8 and 29

• Measurement of the absolute and relative constriction amplitude

  Days 1, 8 and 29

• Measurement of maximum velocity of contraction

  Days 1, 8 and 29

Study Arms (2)

Anthocyan capsules

EXPERIMENTAL

capsules containing 160 mg standardised bilberry extract (25% anthocyanidines)

Drug: Anthocyan capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Anthocyan capsules DRUG

Anthocyan capsules

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: November 1, 1998
• Primary Completion: June 1, 1999
• Last Updated: July 24, 2014

Record last verified: 2014-07