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

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.
 
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

Tracking Information
First Submitted Date  ICMJE April 7, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
Headache frequency and severity [ Time Frame: 10 weeks ]
Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2013)
Photophobia [ Time Frame: 10 weeks ]
Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
Official Title  ICMJE Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Disorders
  • Photophobia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Therapeutic Lens Coating
    Subjects will wear a therapeutic lens coating for 2 weeks
    Interventions:
    • Other: Therapeutic Lens Coating
    • Other: Sham Lens Coating
  • Sham Comparator: Sham Lens Coating
    Subjects will wear a sham lens coating for 2 weeks
    Interventions:
    • Other: Therapeutic Lens Coating
    • Other: Sham Lens Coating
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2014)
48
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2013)
50
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828684
Other Study ID Numbers  ICMJE IRB_00047263
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bradley Katz, University of Utah
Study Sponsor  ICMJE Bradley Katz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradley J Katz, MD University of Utah
PRS Account University of Utah
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP