Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02194361
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2014-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG)', 'timeFrame': 'From day 1 to 28 and from day 57 to day 84'}], 'secondaryOutcomes': [{'measure': 'Changes of the dark adaption using dark flashes', 'timeFrame': 'From day 1 to day 28 and from day 57 to day 84', 'description': 'Pupillography (PG)'}, {'measure': 'Changes of the weakest, correctly recognised contrast level', 'timeFrame': 'From day 1 to day 28 and from day 57 to day 84', 'description': 'Mesoptometry'}, {'measure': 'Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire', 'timeFrame': 'pre-dose on day 1, day 28, pre-dose on day 57, day 84'}, {'measure': 'Assessment of clinical global impression on a 5-point rating scale', 'timeFrame': 'Days 28 and 84'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects (volunteers) with normal twilight and night vision\n* Age 18+, young and collaborative men or women\n* Having given their written informed consent\n* Full visual acuity (vision 0.8 or better) according to DIN Standard condition\n* Refraction ≤ +/-10.0 in the highest main step\n* Normal intraocular pressure (10-20 mmHg)\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Epilepsy\n* Abnormal visual acuity or abnormal morphological eye findings\n* Glaucoma and macula degeneration\n* Disease of the retina\n* Consumption of anthocyan preparations during the past six months\n* 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\n* 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\n* 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)\n* Known hypersensitivity to any of the ingredients of the study drug\n* Drug and alcohol abuse\n* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive\n* Participation in another trial within the past 30 days'}, 'identificationModule': {'nctId': 'NCT02194361', 'briefTitle': 'Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Efficacy of a Bilberry Extract Standardised to a Content of 25% Anthocyanosides in Improving the Night Vision of Healthy Volunteers: a Double-blind, Randomized, Placebo Controlled, Cross-over Trial Over 2 x 28 Days', 'orgStudyIdInfo': {'id': '1147.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anthocyan capsules', 'interventionNames': ['Drug: Anthocyan capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anthocyan capsules', 'type': 'DRUG', 'description': 'Bilberry extract capsules, 160 mg (25% anthocyanosides)', 'armGroupLabels': ['Anthocyan capsules']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}