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.
Patients will be randomised to one of two groups: Group 1 1. Patients wear sham glasses for 4 weeks 2. Patients have 1 week's washout 3. 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. Assuming a fairly conservative SD in the primary endpoint of 8 points, a total of 56 participants would be required to have 90% power to detect a minimum clinically significant difference of 5 points in a two-sample t-test. Allowing for a 20% drop-out rate, 70 participants would need to be recruited. Patients will be in the trial for a total of 13 weeks (4 week run-in, two 4 week periods, with 1 week washout in between).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Migraine episodes are often triggered or exacerbated by environmental factors, particularly light. Active lens has been designed by blocking particular range of wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring. (Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)
Lumishade® Sham lens has been designed as inactive and not blocking particular range of wavelength. Thus, it will not alleviate or prevent symptoms of migraine. (Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)
Headache Impact Test 6
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.
Time frame: up to 13 weeks for each patients participation
Patient diary
A headache diary. A headache diary serves to: * Monitor the frequency, duration and severity of your headaches over time * Identify patterns that may help determine triggers and improve treatment * Track medication use and response * Maintain long term records of what has worked and what has not
Time frame: up to 13 weeks for each patients participation
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