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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Utah
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01942486
First received: June 14, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.


Condition Intervention
Migraine Disorders
Photophobia
Device: Investigational Coating

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • HIT-6 Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being.


Secondary Outcome Measures:
  • Headache Frequency as Measured Using a Self-Reporting Daily Diary [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Headache frequency will be assessed using daily headache diary entries provided by subjects


Other Outcome Measures:
  • Headache Severity as Measured Using a Visual Analog Scale and a Self-Reported Daily Diary [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subjects will rate the severity of their headaches throughout the study using a visual analog scale as part of a daily headache diary.


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Coating Device: Investigational Coating

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
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 at least 10 headache days per month

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, albinism
  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: NCT01942486

Contacts
Contact: Meghan Candee, MD 801-662-1000 meghan.candee@hsc.utah.edu
Contact: Bradley Katz, MD 801-581-2352 bradley.katz@hsc.utah.edu

Locations
United States, Utah
Primary Childrens Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Meghan Candee, MD         
Sponsors and Collaborators
University of Utah
Primary Children's Hospital
Investigators
Principal Investigator: Meghan Candee, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01942486     History of Changes
Other Study ID Numbers: IRB_00065178
Study First Received: June 14, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
migraine
photophobia
light sensitivity
melanopsin cells
intrinsically photosensitive retinal ganglion cells

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

ClinicalTrials.gov processed this record on September 18, 2014