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Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.
Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye 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. The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Endocrinology Research Associates, Inc.
Columbus, Ohio, United States
Remington-Davis Clinical Research
Columbus, Ohio, United States
Start Date
April 6, 2020
Primary Completion Date
August 26, 2020
Completion Date
August 26, 2020
Last Updated
January 9, 2023
78
ACTUAL participants
11-point pain scale
OTHER
Headache diary
OTHER
Avulux®
DEVICE
Sham Avulux®
DEVICE
Lead Sponsor
Avulux, Inc.
Collaborators
NCT07018713
NCT06641466
NCT04715685
Data Source & Attribution
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