Mitsui Chemicals, Inc.
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.
Lumishade® Active Lens
Lumishade® Sham Lens
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 Patients wear active glasses for 4 weeks Patients have 1 week's washout 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|
|Estimated Enrollment :||77 participants|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept Clinical Investigation Designed to Evaluate the Performance of Lumishade® Lens With Frame in Alleviating the Symptoms of Photosensitive Migraine.|
|Actual Study Start Date :||June 30, 2021|
|Estimated Primary Completion Date :||January 4, 2022|
|Estimated Study Completion Date :||April 4, 2022|
Active Comparator: Lumishade® active lens
Treatment of photosensitive migraine with a Lumishade® active device.
Device: Lumishade® Active Lens
Sham Comparator: Lumishade® sham lens
Treatment of photosensitive migraine with a Lumishade® sham device.
Device: Lumishade® Sham Lens
|Ages Eligible for Study:||18 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.