Back to resultsThin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
Primary Purpose
Migraine Disorders, Photophobia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Lens Coating
Sham Lens Coating
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache
Eligibility Criteria
Inclusion Criteria:
- Must be diagnosed with migraine with aura or migraine without aura
- Must have chronic daily migraine (at least 15 headache days per month)
- Age 18 or older
Exclusion Criteria:
- Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
- Pregnant
- Unwilling or unable in the judgment of the investigator to complete the study
- Unavailable for any of the study visits
- Light sensitive conditions: meningitis, iritis, blepharospasm
- Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
- Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
- Best corrected visual acuity less than 20/40 in either eye
Sites / Locations
- John A Moran Eye Center; University of Utah Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Therapeutic Lens Coating
Sham Lens Coating
Arm Description
Subjects will wear a therapeutic lens coating for 2 weeks
Subjects will wear a sham lens coating for 2 weeks
Outcomes
Primary Outcome Measures
HIT-6
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
Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01828684
Brief Title
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
Official Title
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bradley Katz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Photophobia
Keywords
Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Lens Coating
Arm Type
Experimental
Arm Description
Subjects will wear a therapeutic lens coating for 2 weeks
Arm Title
Sham Lens Coating
Arm Type
Sham Comparator
Arm Description
Subjects will wear a sham lens coating for 2 weeks
Intervention Type
Other
Intervention Name(s)
Therapeutic Lens Coating
Intervention Description
Subjects will wear a therapeutic lens coating for 2 weeks.
Intervention Type
Other
Intervention Name(s)
Sham Lens Coating
Intervention Description
Each subject will wear a sham lens coating for 2 weeks.
Primary Outcome Measure Information:
Title
HIT-6
Description
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)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Headache frequency and severity
Description
Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Photophobia
Description
Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be diagnosed with migraine with aura or migraine without aura
Must have chronic daily migraine (at least 15 headache days per month)
Age 18 or older
Exclusion Criteria:
Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
Pregnant
Unwilling or unable in the judgment of the investigator to complete the study
Unavailable for any of the study visits
Light sensitive conditions: meningitis, iritis, blepharospasm
Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
Best corrected visual acuity less than 20/40 in either eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J Katz, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
John A Moran Eye Center; University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
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