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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01828684
Other study ID # IRB_00047263
Secondary ID
Status Completed
Phase N/A
First received April 7, 2013
Last updated March 30, 2016
Start date March 2013
Est. completion date February 2014

Study information

Verified date March 2016
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.
Sham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.

Locations

Country Name City State
United States John A Moran Eye Center; University of Utah Hospitals and Clinics Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Bradley Katz

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Photophobia Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire. 10 weeks No
Primary 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) 10 weeks No
Secondary Headache frequency and severity Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries. 10 weeks No
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