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

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ClinicalTrials.gov Identifier: NCT01828684
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Bradley Katz, University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Photophobia Other: Therapeutic Lens Coating Other: Sham Lens Coating Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
Study Start Date : March 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks
 Other: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.

Other: Sham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.
Sham Comparator: Sham Lens Coating
Subjects will wear a sham lens coating for 2 weeks
 Other: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.

Other: Sham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Headache frequency and severity [ Time Frame: 10 weeks ]
    Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.


Other Outcome Measures:
  1. Photophobia [ Time Frame: 10 weeks ]
    Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828684


Locations
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United States, Utah
John A Moran Eye Center; University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Bradley Katz
Investigators
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Principal Investigator: Bradley J Katz, MD University of Utah
More Information
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Responsible Party: Bradley Katz, Associate Professor of Ophthalmology & Neurology, University of Utah
ClinicalTrials.gov Identifier: NCT01828684    
Other Study ID Numbers: IRB_00047263
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by Bradley Katz, University of Utah:
Migraine with Aura
Migraine without Aura
Photophobia
Chronic Daily Headache
Additional relevant MeSH terms:
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Migraine Disorders
Photophobia
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations
Vision Disorders
Sensation Disorders
Eye Diseases