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

Not Applicable

Completed

• Conditions: Photophobia; Migraine Disorders
• Interventions: Other: Therapeutic Lens Coating; Other: Sham Lens Coating

• Registration Number: NCT01828684
• Lead Sponsor: Bradley Katz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have chronic daily migraine (at least 15 headache days per month)
3. Age 18 or older

Exclusion Criteria

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Lens Coating	Sham Lens Coating	Subjects will wear a sham lens coating for 2 weeks
Therapeutic Lens Coating	Therapeutic Lens Coating	Subjects will wear a therapeutic lens coating for 2 weeks
Therapeutic Lens Coating	Sham Lens Coating	Subjects will wear a therapeutic lens coating for 2 weeks
Sham Lens Coating	Therapeutic Lens Coating	Subjects will wear a sham lens coating for 2 weeks

Primary Outcome Measures

Name	Time	Method
HIT-6	10 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Headache frequency and severity	10 weeks	Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.

Trial Locations

Locations (1)

John A Moran Eye Center; University of Utah Hospitals and Clinics; 🇺🇸 Salt Lake City, Utah, United States