Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
The purpose of this research is to assess how well the Avulux® migraine lenses work in
 reducing the impact of migraine headaches as measured by improvement in an 11-point pain
 scale after two and four hours of device application, when compared to a control device.
Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with
 episodic migraine headaches. In this study, the investigative Avulux® device shall consist of
 a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle
 frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges
 while minimizing distortion of the visible spectrum. The optical filters block a portion of
 the optical spectrum that is suspected to stimulate photophobic responses that trigger some,
 and exacerbate most, migraines.

 The control/sham device for this study shall be a pair of plastic lenses provided in a
 standard spectacle frame, which will have negligible light-blocking properties at the optical
 wavelengths which are blocked by the Avulux® device.
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