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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01828684
First Posted: April 11, 2013
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bradley Katz, University of Utah
  Purpose
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 Intervention
Migraine Disorders Photophobia Other: Therapeutic Lens Coating Other: Sham Lens Coating

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Bradley Katz, University of Utah:

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


Enrollment: 48
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Bradley J Katz, MD University of Utah
  More Information

Responsible Party: Bradley Katz, Associate Professor of Ophthalmology & Neurology, University of Utah
ClinicalTrials.gov Identifier: NCT01828684     History of Changes
Other Study ID Numbers: IRB_00047263
First Submitted: April 7, 2013
First Posted: April 11, 2013
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:
Migraine Disorders
Headache
Photophobia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Vision Disorders
Sensation Disorders
Eye Diseases