Clinical & Scientific Resources
Clinical Studies
2016 – Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
A lens blocking light specifically at the 480nm wavelength was compared to another lens blocking light at 620nm to measure their efficacy at reducing the impact of a migraine attack as measured by the HIT-6 Test, a test specifically designed to measure the effect of migraine attacks on quality of life and activities of daily living. More than half 19/37 subjects wearing one of these lenses showed at least a one level clinical improvement, opening the door to the development of the current Avulux lens.
Published research: https://pubmed.ncbi.nlm.nih.gov/26935748/
2020 – Double Blind, Randomized, Sham-Controlled Trial
In this study, the Avulux lens was compared with a true clear sham lens that did not significantly block any of the wavelengths that are associated with migraine attacks. 79 subjects completed the three week study that measured migraine pain level, using an 11 point pain scale (a drop of approximately 1.8 points was considered clinically significant as validated by many other unrelated trials), at the onset of a migraine attack, and both 2 hours and 4 hours after application of the Avulux or sham lens. The presence or absence of light sensitivity was also measured at both 2 and 4 hours after the attack. The results demonstrated that if the Avulux lens was applied within the first hour after the onset of a migraine attack, if all headaches that a study subject had during the clinical trial period were included, and if no abortive medications were taken, that Avulux was both statistically and clinically superior to the sham lens. This is the highest scientific standard of efficacy.
Trial information: https://clinicaltrials.gov/ct2/show/NCT04341298
Peer reviewed publication: Journal of Clinical Neuroscience.
2025 - Avulux Lens Increases Visual Photosensitivity Discomfort Thresholds in Healthy Volunteers
In a controlled laboratory study, researchers found that Avulux lenses significantly increased visual photosensitivity discomfort thresholds compared with clear control lenses, meaning participants could tolerate more light before it became uncomfortable. The lenses were engineered to selectively filter light at 480 nm and 590 nm, wavelengths associated with visual discomfort, and the effect was independent of participant expectation (i.e., not driven by placebo). The study used quantitative sensory testing with the Ocular Photosensitivity Analyzer (OPA) and was conducted by teams at Harvard Medical School / Boston Children’s Hospital and the University of Miami Miller School of Medicine.
https://iovs.arvojournals.org/article.aspx?articleid=2803836
Background Research on Light Sensitivity and Migraine
Digre KB, Brennan KC. Shedding light on photophobia. J Neuroophthalmol. 2012;32(1):68–81.
https://doi.org/10.1097/WNO.0b013e3182474548
Wu Y, Hallett M. Photophobia in neurologic disorders. Transl Neurodegener. 2017;6:26.
https://doi.org/10.1186/s40035-017-0095-3
Patents
Patent No: 9759848
View more patents here.
Indications for Use
Avulux® is an FDA-authorized, over-the-counter precision optical filter indicated to block light at 480 nm (high blue range) and 590 nm (red/amber range), while allowing light in the remaining visible color spectrum through, to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years and older. The use of Avulux should not alter the usual care therapy of patients diagnosed with episodic migraine, including medication usage.
Avulux is intended to be used as an adjunct to usual care for migraine, including medication. It is not intended to diagnose, treat, cure, or prevent migraine or any other disease and is not a substitute for professional medical advice, diagnosis, or treatment. Consult a qualified healthcare professional regarding migraine symptoms and treatment. Avulux is classified by the U.S. Food and Drug Administration as a Class I medical device under 21 CFR § 882.5811, product code QEO. De Novo request DEN250026.
