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A Proof of Concept Clinical Investigation Designed to Evaluate the Performance of Lumishade® Lens With Frame in Alleviating the Symptoms of Photosensitive Migraine.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
June 30, 2021
Primary Completion Date
January 4, 2022
Completion Date
April 4, 2022
Last Updated
May 27, 2021
77
ESTIMATED participants
Lumishade® Active Lens
DEVICE
Lumishade® Sham Lens
DEVICE
Lead Sponsor
Mitsui Chemicals, Inc.
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
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