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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bradley Katz, University of Utah
ClinicalTrials.gov Identifier:
NCT01828684
First received: April 7, 2013
Last updated: February 9, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Utah:

Primary Outcome Measures:
  • HIT-6 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.


Other Outcome Measures:
  • Photophobia [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 7, 2013
Last Updated: February 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Migraine with Aura
Migraine without Aura
Photophobia
Chronic Daily Headache

Additional relevant MeSH terms:
Headache
Photophobia
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vision Disorders
Sensation Disorders
Eye Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014