Thin Film Optical Notch Filter Spectacle Coatings for the Treatment of
Migraine and Photophobia
Our “first” clinical trial showed for the first time that optical filters not only reduce light sensitivity and photophobia, they can reduce the frequency and severity of migraine headaches, and the effect these headaches have on everyday living (“headache impact”). In this trial, the primary outcome was the Headache Impact Test (HIT-6), an instrument clinicians use to assess how headaches impact activities of daily living, such as work, school and social activities. At baseline, 89% of our study subjects had scores greater than 60, indicating their headaches were having a “very severe” impact on their lives. While wearing the optical notch filters, 58% of these subjects had reductions in their HIT-6 scores that were significant enough to move them out of this “very severe” category. Click here to read the full article>>>
We successfully executed this trial, published the results in a “peer-reviewed journal”, and presented the results to the FDA. The knowledge we gained in this trial and our subsequent meeting with the FDA enabled us to engage our biostatisticians to more confidently design the larger trial currently underway.