Mitsui Lumishade ® LUMIS001
Research type
Research Study
Full title
A proof of concept clinical investigation designed to evaluate the performance of the Lumishade® Lens with a Selected Frame in alleviating the symptoms of photosensitive migraine.
IRAS ID
273901
Contact name
Farooq Maniyar
Contact email
Sponsor organisation
Mitsui Chemicals, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Summary of Research
Migraines are deemed the most common neurological problem globally. They often cause debilitating effects when a severe headache occurs, but headaches are not the only symptoms of migraines. There are many indicators that patients may be suffering from a migraine. Still, the most common symptoms people experience in addition to headaches are nausea and sensitivity to external stimuli like light, smell, and movement. About 25% of patients suffering a migraine experience aura which can be visual, but they may also suffer from sensory, language or motor problems. By far, visual aura is the most common symptom alongside a headache.Migraine prevalence has a strong genetic component. Approximately 70% of migraine patients have a first-degree relative with a history of migraine. The risk of a person suffering a migraine is increased 4-fold in relatives of people who have migraine with aura. Recent genetic research suggests there could be up to 4 regions on a person’s DNA that indicate you are likely to suffer from hereditary migraines, but further work is required to determine this.
The purpose of this study is for us to assess the effectiveness of the recently designed Lumishade® lens with selected frame shown within the patient information sheet enclosed. A company called Mitsui Chemicals, Inc. have designed the lenses specifically to cut out blue light wavelengths. The study aims to evaluate the ability of the Lumishade® lens with frame to alleviate symptoms of photosensitive migraine. This randomised trial will aim to determine whether wearing the Lumishade® lens with frame successfully reduces the symptoms of migraine, compared to wearing sham glasses.
Summary of Results
Ultimately, the clinical trial included eighty-eight patients who were screened, and seventy-six were randomized to use the glasses. Patients included in the trial had a history of migraine with or without aura and light-sensitive migraine.
The main endpoint, or the primary measure used to identify any difference between Lumishade and sham glasses, was the HIT-6 form. HIT-6 is a validated headache questionnaire that asks patients six questions about the impact of headache on daily life over the previous four weeks. Other endpoints were also assessed to identify any differences in the number of migraines and headaches and the effect of light. After the actual test was completed, we carefully analyzed the results. However, unfortunately, we did not find any significant differences between the effects of Lumishade and sham glasses for any of the endpoints. This suggests that Lumishade does not have any meaningful protective effect on light-sensitive migraine.
On the other hand, the positive outcome is that there were no significant adverse events noted in the study, suggesting the use of Lumishade glasses in this population can be safe.REC name
South East Scotland REC 02
REC reference
21/SS/0008
Date of REC Opinion
10 Mar 2021
REC opinion
Further Information Favourable Opinion