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

NCT03902496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

HIT-6 Questionnaire

Headache Impact Test

DEVICE

Avulux Spectacles

Avulux™ Optical Filter in the Form of Spectacle Lenses

DEVICE

Sham Spectacles

Sham

Sponsors & Collaborators

  • Avulux, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2019-05-17
Completion
2019-05-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03902496 on ClinicalTrials.gov