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Spectacle Tints and Thin-Films for Migraine

NCT02720211 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-29

Study results available
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Summary

Nearly all migraine sufferers report sensitivity to light during a headache and a significant proportion of sufferers report light sensitivity between attacks. Light is also a common trigger for migraine headaches. Spectacle lenses that have been treated with tints and spectacle lenses that have been treated with thin-films have both been shown to reduce light sensitivity and headache in patients with migraine. At this time, it is not clear which spectacle lens treatment is superior. The purpose of this trial is to determine if there's a significant, therapeutic advantage to either spectacle lens treatment. Both treatments could be a novel, non-invasive adjuvant in the treatment of migraine.

Conditions

  • Headache Migraine Chronic

Interventions

DEVICE

Gray tinted spectacle lenses

A neutral gray optical tint designed to block all wavelengths in the visible spectrum

DEVICE

Thin-Film spectacle lenses

A thin film optical notch filter designed to block 480-nm light in the visible spectrum

Sponsors & Collaborators

  • Axon Optics, LLC

    collaborator INDUSTRY

  • Mayo Clinic

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Northwell Health

    collaborator OTHER

  • University of Utah

    lead OTHER

Principal Investigators

  • Bradley Katz, MD · Axon Optics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-11-06
Completion
2018-11-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720211 on ClinicalTrials.gov