Spectacle Tints and Thin-Films for Migraine

NCT02720211 | Terminated Results

• 1 other identifier: IRB #86498
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

headache; photophobia; migraine; light sensitivity; tints; thin films

Outcome Measures

Primary Outcomes (1)

• Headache Frequency

  average number of days (in one month) with at least one headache lasting at least 4 hours

  one month

Secondary Outcomes (1)

• Headache Impact

  one month

Study Arms (2)

Gray tinted spectacle lenses

ACTIVE COMPARATOR

Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally

Device: Gray tinted spectacle lenses

Thin-Film spectacle lenses

EXPERIMENTAL

Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength

Device: Thin-Film spectacle lenses

Interventions

Gray tinted spectacle lenses DEVICE

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

Gray tinted spectacle lenses

Thin-Film spectacle lenses DEVICE

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

Thin-Film spectacle lenses

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the International Headache Society criteria for chronic migraine (International Classification of Headache Disorders, 3rd edition (Headache Classification Committee of the International Headache Society, 2013). All subjects must be between the ages of 18 and 60 years-old.
• To be included in the study, in the best judgment of the investigator, subjects must be stable on their current migraine treatment regimen. Stability is defined as no major changes in therapy contemplated within the next 4 months.

You may not qualify if:

• Subjects with other light sensitive conditions, such as iritis and blepharospasm, will be excluded. Subjects with best-corrected visual acuity less than 20/40 will be excluded. Subjects with diseases of the retina, such as diabetic retinopathy and macular degeneration will be excluded. Subjects using medications known to affect the eye will be excluded (e.g. chloroquine, hydroxychloroquine, ethambutol, amiodarone). Due to constraints on the manufacture and mounting of study lenses into study frames, the study must exclude subjects who are very nearsighted (more than 4 diopters), subjects who are very farsighted (more than 2 diopters), and subjects who have more than 2.5 diopters of astigmatism.
• Because of the cyclical effects of botulinum toxin injections and other nerve blocks, patients undergoing these treatments will be excluded. Subjects must not have had any injections or blocks within 4 months of enrollment and should not receive any further blocks until they exit the study.
• Subjects with continuous daily headache (a headache frequency of 100%) will be excluded. Subjects who do not have a headache frequency of at least 50% will be excluded.
• Subjects with medication overuse headache will be excluded. A patient with a history of medication overuse who has not overused abortive medications for the past 4 months can be included.
• Subjects who abuse alcohol or use illicit drugs will be excluded. Subjects considered to be from vulnerable populations will be excluded, including pregnant women, prisoners, subject who are mentally disabled, subjects with cognitive or decisional impairment, and wards of the state

Sponsors & Collaborators

• University of Utah: lead
• Axon Optics, LLC: collaborator
• Mayo Clinic: collaborator
• Brigham and Women's Hospital: collaborator
• Northwell Health: collaborator

Study Sites (4)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Brigham and Women's Hospital; John R Graham Headache Center; Harvard University,

Boston, Massachusetts, 02130, United States

Location

Headache Center of the Neuroscience Institute; Hofstra Northwell Health; Northshore University Hospital

Great Neck, New York, 11021, United States

Location

John A Moran Eye Center; University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Headache; Photophobia; Migraine Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Nervous System Diseases; Eye Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Axon Optics

bradley.katz@hsc.utah.edu

8012304851

Study Officials

• Bradley Katz, MD

  Axon Optics, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: August 1, 2016
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: November 29, 2022
• Results First Posted: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)