Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine

Study Overview
=================
Brief Summary
-----------------
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.

Official Title
-----------------
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.

Conditions
-----------------
Migraine Disorders, Photophobia

Intervention / Treatment
-----------------
* Other: Therapeutic Lens Coating
* Other: Sham Lens Coating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be diagnosed with migraine with aura or migraine without aura Must have chronic daily migraine (at least 15 headache days per month) Age 18 or older Exclusion Criteria: Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity Pregnant Unwilling or unable in the judgment of the investigator to complete the study Unavailable for any of the study visits Light sensitive conditions: meningitis, iritis, blepharospasm Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs Best corrected visual acuity less than 20/40 in either eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Lens Coating<br>Subjects will wear a therapeutic lens coating for 2 weeks | Other: Therapeutic Lens Coating<br>* Subjects will wear a therapeutic lens coating for 2 weeks.<br>Other: Sham Lens Coating<br>* Each subject will wear a sham lens coating for 2 weeks.<br>|
| Sham Comparator: Sham Lens Coating<br>Subjects will wear a sham lens coating for 2 weeks | Other: Therapeutic Lens Coating<br>* Subjects will wear a therapeutic lens coating for 2 weeks.<br>Other: Sham Lens Coating<br>* Each subject will wear a sham lens coating for 2 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIT-6 | Primary outcome measure is improvement in HIT-6 while wearing therapeutic lenses compared to baseline. The HIT-6 is the Headache Impact Test, a trademarked and copyrighted test (2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency and severity | Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache