Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Detailed Description
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Avulux™ is intended to decrease the impact of headache and migraine on normal daily life and the ability to function, and reduce the frequency and severity of headache, in adult patients diagnosed with episodic migraine headache or chronic migraine. Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film 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.

Official Title
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Optical Treatment of Migraines Clinical Study

Conditions
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Migraine

Intervention / Treatment
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* Other: HIT-6 Questionnaire
* Device: Avulux Spectacles
* Device: Sham Spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years or older Patient is willing and able to provide written informed consent Patient is willing and able to complete all scheduled study visits Diagnosis of migraine, based on the following primary headache characteristics: At least 5 attacks fulfilling criteria b-d: 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 (eg, walking or climbing stairs) During headache at least one of the following: nausea and/or vomiting photophobia and phonophobia Not attributed to another disorder Exclusion Criteria: Patients with other light sensitive conditions, such as iritis. Patients who have less than 4 headache days per month Patients who have chronic daily headaches. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A total of 50 subjects will be randomized into one of two treatment groups in a one-to-one ratio. After three weeks, and following a one-week washout period, subjects will be given spectacles from the other treatment group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avulux Spectacles<br>Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved. | Other: HIT-6 Questionnaire<br>* Headache Impact Test<br>Device: Avulux Spectacles<br>* Avulux™ Optical Filter in the Form of Spectacle Lenses<br>|
| Sham Comparator: Sham Spectacles<br>Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved. | Other: HIT-6 Questionnaire<br>* Headache Impact Test<br>Device: Sham Spectacles<br>* Sham<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Impact Test (HIT-6) total score | The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6) scores at three weeks when compared to a control/sham device. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. | Three-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Headache Days | To measure effects on the number and severity of headaches, we will use the subjects' daily diaries to count the number of days with headache that either a) made activity difficult, b) caused activity changes, or c) caused patient to go to bed. We will then compare the proportion of days with headaches that met one of these criteria for the 4-week baseline period and the 3-week intervention. | Three-week |