Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

Inclusion Criteria

• Subject is 18 years or older
• Subject is willing and able to provide written informed consent
• Diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics:
• Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
• Headache has at least two of the following characteristics:
• unilateral location
• pulsating quality
• moderate or severe pain intensity
• aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
• Headache occurs with at least one of the following symptoms:
• nausea and/or vomiting
• photophobia and phonophobia
• Subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications
• Migraines are not attributed to another disorder

Exclusion Criteria

• Subjects participating in another prospective, interventional clinical study
• Subjects with other light sensitive conditions, such as iritis
• Subjects who have less than 4 headache days per month with the above characteristics
• Chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month)
• Subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months)
• Subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment
• Subjects whose family members are currently participating in this study, or are employees of the study site, Avulux, or the coordinating CRO