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

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ClinicalTrials.gov Identifier: NCT01942486
Recruitment Status : Terminated
First Posted : September 16, 2013
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
Bradley Katz, University of Utah

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE September 16, 2013
Results First Submitted Date  ICMJE April 12, 2019
Results First Posted Date  ICMJE March 26, 2020
Last Update Posted Date March 26, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
HIT-6 Score [ Time Frame: 12 weeks ]
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. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
HIT-6 Score [ Time Frame: 12 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
Headache Frequency as Measured Using a Self-Reporting Daily Diary [ Time Frame: 12 weeks ]
Headache frequency will be assessed using daily headache diary entries provided by subjects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 10, 2013)
Headache Severity as Measured Using a Visual Analog Scale and a Self-Reported Daily Diary [ Time Frame: 12 weeks ]
Subjects will rate the severity of their headaches throughout the study using a visual analog scale as part of a daily headache diary.
 
Descriptive Information
Brief Title  ICMJE Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Official Title  ICMJE Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Disorders
  • Photophobia
Intervention  ICMJE Device: Investigational Coating
Study Arms  ICMJE Experimental: Investigational Coating
Intervention: Device: Investigational 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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
30
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, 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 NCT01942486
Other Study ID Numbers  ICMJE IRB_00065178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bradley Katz, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Primary Children's Hospital
Investigators  ICMJE
Principal Investigator: Bradley Katz, MD University of Utah
PRS Account University of Utah
Verification Date March 2020

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