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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine Disorders Photophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Therapeutic Lens Coating

Subjects will wear a therapeutic lens coating for 2 weeks

Group Type EXPERIMENTAL

Therapeutic Lens Coating

Intervention Type OTHER

Subjects will wear a therapeutic lens coating for 2 weeks.

Sham Lens Coating

Intervention Type OTHER

Each subject will wear a sham lens coating for 2 weeks.

Sham Lens Coating

Subjects will wear a sham lens coating for 2 weeks

Group Type SHAM_COMPARATOR

Therapeutic Lens Coating

Intervention Type OTHER

Subjects will wear a therapeutic lens coating for 2 weeks.

Sham Lens Coating

Intervention Type OTHER

Each subject will wear a sham lens coating for 2 weeks.

Interventions

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Therapeutic Lens Coating

Subjects will wear a therapeutic lens coating for 2 weeks.

Intervention Type OTHER

Sham Lens Coating

Each subject will wear a sham lens coating for 2 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No