A Proof of Concept Clinical Investigation Designed to Evaluate the Performance of Lumishade® Lens With Frame in Alleviating the Symptoms of Photosensitive Migraine.
试验速览
- 阶段
- 不适用
- 入组人数
- 77
- 主要终点
- Headache Impact Test 6
研究概览
简要总结
This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity.
The spectacles cut out blue light wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring.
详细描述
Patients will be randomised to one of two groups:
Group 1
- Patients wear sham glasses for 4 weeks
- Patients have 1 week's washout
- Patients wear active glasses for 4 weeks
Group 2 4. Patients wear active glasses for 4 weeks 5. Patients have 1 week's washout 6. Patients wear sham glasses for 4 weeks
The study will aim to determine whether wearing the active lens successfully reduces the symptoms of migraine, compared to wearing sham lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Diagnosis of migraine before the age of 50, confirmed though screening consultation with the patient
- •Willing and able to provide written informed consent
- •Willing to comply with study assessment schedule and patient diary entry
- •Diagnosis of migraine, with or without aura based on the following primary headache characteristics (based on the Revised International Headache Society criteria for migraine headache)
- •At least 5 attacks fulfilling criteria B-D
- •Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- •Headache has at least two of the following characteristics:
- •i. unilateral location ii. pulsating quality iii. moderate or severe pain intensity iv. aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) d. During headache at least one of the following: i. nausea and/or vomiting ii. photophobia and phonophobia e. Not attributed to another disorder
- •Migraine associated with photophobia i.e. either photic hypersensitivity or photic allodynia or inter-ictal photophobia or migraine triggered by light according to patient or a combination of these 4 factors
- •No expected changes of headache preventative medications after enrolment
排除标准
- •Patients with other light sensitive conditions, such as iritis or retinal disease.
- •Patients who have less than 4 headache days per month
- •Patients who have daily headaches.
- •Pregnant or nursing
- •History of cluster headache or hemiplegic migraine
- •Evidence of seizure or major psychiatric disorder
- •Score of 19 or higher on the BDI
- •Active chronic pain syndrome
- •Cardiac or hepatic disease
- •Have taken any investigational medication within 12 weeks before randomization, or are scheduled to receive an investigational drug
- •Have received Botox injections for any purpose in the head or face region within 3 months of trial onset or scheduled to receive such treatment during the trial
- •Medication overuse as per the revised ICHD-3 IHS criteria
- •Medications that can affect light perception like ethambutol, hydroxychloroquine or amiodarone or any other according to the opinion of the investigator
- •Patients requiring prescription/reading glasses
- •Patients who have not responded to three or more migraine preventive drugs
- •Patients who have a diagnosed neurological disorder that may influence the study according to the investigators
结局指标
主要结局
Headache Impact Test 6
时间窗: up to 13 weeks for each patients participation
The primary endpoint is the change in Headache Impact Test (HIT-6) score from end of run-in (Baseline) to end of treatment period following 4 weeks of treatment. The HIT 6 questionnaire is a licensed questionnaire with standardised calculations to assess the responses to the questions in the questionnaire.
次要结局
- Patient diary(up to 13 weeks for each patients participation)