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Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Optical Treatment of Migraines Clinical Study

NCT03902496•Avulux, Inc.

Summary

The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Detailed Description

Avulux™ is intended to decrease the impact of headache and migraine on normal daily life and the ability to function, and reduce the frequency and severity of headache, in adult patients diagnosed with episodic migraine headache or chronic migraine. Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is 18 years or older
•2. Patient is willing and able to provide written informed consent
•3. Patient is willing and able to complete all scheduled study visits
•4. Diagnosis of migraine, based on the following primary headache characteristics:
•1. At least 5 attacks fulfilling criteria b-d:
•2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
•3. Headache has at least two of the following characteristics:
•* unilateral location
•* pulsating quality
•* moderate or severe pain intensity
+5 more criteria

Exclusion Criteria

•1. Patients with other light sensitive conditions, such as iritis.
•2. Patients who have less than 4 headache days per month
•3. Patients who have chronic daily headaches.
•4. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Locations (1)

Remington-Davis Clinical Research

Columbus, Ohio, United States

Key Dates

Start Date

March 18, 2019

Primary Completion Date

May 17, 2019

Completion Date

May 17, 2019

Last Updated

July 5, 2019

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

HIT-6 Questionnaire

OTHER

Avulux Spectacles

DEVICE

Sham Spectacles

DEVICE

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

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Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

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Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.