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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02194127
• Collaborator: (none)
• Enrollment: 195
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Anthocyan capsules; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Tolerability of a Treatment Over 28 Days With a Bilberry Extract Standardised to a Content of 25% Anthocyanidines in Volunteers With Impaired Twilight and Night Vision
• Study Start Date: Nov 1, 1998
• Actual Primary Completion Date: Jun 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anthocyan capsules capsules containing 160 mg standardised bilberry extract (25% anthocyanidines)	Drug: Anthocyan capsules
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Measurement of the maximum velocity of dilatation of the pupil [day 29]

Secondary Outcome Measures

1. Measurement of the maximum velocity of dilatation of the pupil [Days 1 and 8]

2. Measurement of the initial pupil diameter [days 1, 8 and 29]

3. Measurement of the latency time [Days 1, 8 and 29]

4. Measurement of the absolute and relative constriction amplitude [Days 1, 8 and 29]

5. Measurement of maximum velocity of contraction [Days 1, 8 and 29]

6. Measurement of velocity of contraction 2 [Days 1, 8 and 29]

7. Measurement of initial minimal contrast level [Days 1, 8 and 29]

   Determined with Gecko Contrast card

8. Time to regain contrast vision at one level above the initial minimal contrast [days 1, 8 and 29]

   Determined with Gecko Contrast card

9. Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare [Days 1, 8 and 29]

   determined with Mesoptometer II

10. Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare [Days 1, 8 and 29]

    determined with Mesoptometer II

11. Recovery time after dazzling [Days 1, 8 and 29]

12. Change of potential (µVolt) in retina due to photo activation [Baseline, days 1, 8 and 29]

    Measured with Standard Electroretinography (ERG)

13. Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire [Pre-dose and days 1, 8 and 29]

14. Assessment of clinical global impression on a 5-point rating scale [Day 29]

15. Number of patients with adverse events [up to day 29]

16. Number of patients with significant changes in laboratory parameters [Baseline and day 29]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02194127
• Other Study ID Numbers: 1147.2
• First Posted: Jul 18, 2014
• Last Update Posted: Jul 24, 2014
• Last Verified: Jul 1, 2014

Study Results

No Results Posted as of Jul 24, 2014