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Spectacle Tints and Thin-Films for Migraine

Primary Purpose

Headache Migraine Chronic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gray tinted spectacle lenses

Thin-Film spectacle lenses

About this trial

This is an interventional treatment trial for Headache Migraine Chronic focused on measuring headache, photophobia, migraine, light sensitivity, tints, thin films

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Mayo Clinic
Brigham and Women's Hospital; John R Graham Headache Center; Harvard University,
Headache Center of the Neuroscience Institute; Hofstra Northwell Health; Northshore University Hospital
John A Moran Eye Center; University of Utah Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gray tinted spectacle lenses

Thin-Film spectacle lenses

Arm Description

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

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

Outcomes

Primary Outcome Measures

Headache Frequency

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

Secondary Outcome Measures

Headache Impact

Headache impact as measured by the headache impact test (HIT-6) HIT-6 total score range between 36 and 78, with larger scores reflecting greater impact Scores less than or equal to 49 = Little or no impact Scores between 50 and 55 = Some impact Scores between 56 and 59 = Substantial impact Scores 60 or great = Severe impact

Full Information

NCT ID

NCT02720211

First Posted

March 21, 2016

Last Updated

November 6, 2022

Sponsor

University of Utah

Collaborators

Axon Optics, LLC, Mayo Clinic, Brigham and Women's Hospital, Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02720211

Brief Title

Spectacle Tints and Thin-Films for Migraine

Official Title

Spectacle Tints and Thin-Films to Reduce Headache Frequency in Patients With Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Too difficult to enroll according to inclusion/exclusion criteria

Study Start Date

August 2016 (Actual)

Primary Completion Date

November 6, 2018 (Actual)

Study Completion Date

November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

Axon Optics, LLC, Mayo Clinic, Brigham and Women's Hospital, Northwell Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Approximately 6% of men and 18% of women are afflicted with migraines. (Stovner et al., 2006) Over 90% of patients with migraines report a sensitivity to light (photophobia) during headaches. (Evans et al., 2008) Some migraine sufferers report that light can trigger a migraine and some have a chronic sensitivity to light (Main et al., 1997). Migraineurs are especially sensitive to non-incandescent lighting sources such as fluorescent lights, computer monitors, and gas-vapor lamps (Katz and Digre, 2016). The pathway that mediates photophobia appears to involve intrinsically photosensitive retinal ganglion cells ("IPRGCs"; Hattar et al., 2002) and trigeminal afferents (Noseda et al., 2010; Digre and Brennan, 2012). These retinal cells do not require input from photoreceptors to be activated by light, and they have been shown to be responsible for circadian rhythm entrainment and the pupillary light reflex. As such, these cells constitute a pathway separate from that of the visual pathway (Güler et al., 2008). IPRGCs contain the chromophore melanopsin. In these cells, 480 nm light (in the blue-green portion of the visible spectrum) isomerizes melanopsin and triggers the phototransduction cascade. However, IPRGCs can also be stimulated by rods and cones. Thus, IPRGCs can be stimulated directly by 480-nm light or indirectly by any light in the visible spectrum. In the present study, the investigators will use a neutral gray tint to decrease stimulation of the eye by all wavelengths in the visible spectrum. The investigators will compare this intervention to a thin-film spectacle coating designed to specifically block 480-nm light. The gray tint will decrease both direct and indirect stimulation of the IPRGCs by blocking all wavelengths of the visible spectrum. The 480-nm thin-film will specifically target direct stimulation of the IPRGC. All tints and thin films will be calibrated such that the optical density, that is the overall "darkness" of all study lenses, will be the same. All study lenses will appear to have the same overall light blocking effect to study subjects. The lenses are intended to be a preventative or prophylactic treatment for chronic migraine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache Migraine Chronic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gray tinted spectacle lenses

Arm Type

Active Comparator

Arm Description

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

Arm Title

Thin-Film spectacle lenses

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Gray tinted spectacle lenses

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Thin-Film spectacle lenses

Intervention Description

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

Primary Outcome Measure Information:

Title

Headache Frequency

Description

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

Time Frame

one month

Secondary Outcome Measure Information:

Title

Headache Impact

Description

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley Katz, MD

Organizational Affiliation

Axon Optics, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

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

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

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

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Spectacle Tints and Thin-Films for Migraine

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