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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828684
• Other study ID #: IRB_00047263
• 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

• Headache
• Migraine Disorders
• Photophobia

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