NCT02194127已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 195
- 主要终点
- Measurement of the maximum velocity of dilatation of the pupil
研究概览
简要总结
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Diabetes mellitus
- •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
研究组 & 干预措施
Anthocyan capsules
Experimental
capsules containing 160 mg standardised bilberry extract (25% anthocyanidines)
干预措施: Anthocyan capsules (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Measurement of the maximum velocity of dilatation of the pupil
时间窗: day 29
次要结局
- Measurement of maximum velocity of contraction(Days 1, 8 and 29)
- Measurement of velocity of contraction 2(Days 1, 8 and 29)
- Measurement of initial minimal contrast level(Days 1, 8 and 29)
- 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)
- Time to regain contrast vision at one level above the initial minimal contrast(days 1, 8 and 29)
- Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare(Days 1, 8 and 29)
- Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare(Days 1, 8 and 29)
- Recovery time after dazzling(Days 1, 8 and 29)
- Change of potential (µVolt) in retina due to photo activation(Baseline, days 1, 8 and 29)
- Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire(Pre-dose and days 1, 8 and 29)
- Assessment of clinical global impression on a 5-point rating scale(Day 29)
- Number of patients with adverse events(up to day 29)
- Number of patients with significant changes in laboratory parameters(Baseline and day 29)
研究者
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