Skip to main content
OpenTrials
Completed

NCT Number: NCT01828684

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Eye Diseases Headache Disorders Headache Disorders, Primary Migraine with Aura Migraine without Aura Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Photophobia Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John A Moran Eye Center; University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Lens Coating

Other

Subjects will wear a therapeutic lens coating for 2 weeks.

Sham Lens Coating

Other

Each subject will wear a sham lens coating for 2 weeks.

Primary outcomes

  1. HIT-6

    Time frame: 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 outcomes

  1. Headache frequency and severity

    Time frame: 10 weeks

    Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.

Other outcomes

  1. Photophobia

    Time frame: 10 weeks

    Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.

Sponsors and collaborators

Lead sponsor

Bradley Katz

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.