Headache Migraine ChronicNCT02720211
Spectacle Tints and Thin-Films for Migraine
A study testing Gray tinted spectacle lenses and Thin-Film spectacle lenses in people with Headache Migraine Chronic, run by University of Utah at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache Migraine Chronic
- What is being tested?
- Gray tinted spectacle lenses and Thin-Film spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2016to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital; John R Graham Headache Center; Harvard University,
Boston, Massachusetts, 02130
Headache Center of the Neuroscience Institute; Hofstra Northwell Health; Northshore University Hospital
Great Neck, New York, 11021
Mayo Clinic
Phoenix, Arizona, 85054
John A Moran Eye Center; University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
About this study
Official title: Spectacle Tints and Thin-Films to Reduce Headache Frequency in Patients With Chronic Migraine
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.
Read the 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.
- Conditions
- Headache Migraine Chronic
- Being tested
- Gray tinted spectacle lenses, Thin-Film spectacle lenses
- Keywords
- headache, photophobia, migraine, light sensitivity, tints, thin films
- Medical subject headings
- Headache, Photophobia, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gray tinted spectacle lensesDevice
A neutral gray optical tint designed to block all wavelengths in the visible spectrum
Thin-Film spectacle lensesDevice
A thin film optical notch filter designed to block 480-nm light in the visible spectrum
| Study group | Role | What they receive |
|---|---|---|
| Gray tinted spectacle lenses | Active comparator | Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally Receives: 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 Receives: Device: Thin-Film spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency
average number of days (in one month) with at least one headache lasting at least 4 hours
Measured: one month
Secondary outcomes (1)
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Why it stopped: Too difficult to enroll according to inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Headache Migraine ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Axon Optics, LLC, Mayo Clinic, Brigham and Women's Hospital, Northwell Health
- Responsible party
- Principal investigator, Bradley Katz, University of Utah
- Investigators
- Bradley Katz, MD, Principal investigator, Axon Optics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720211
- Sponsor's protocol ID
- IRB #86498
- Status last verified
- Nov 2022
- First submitted
- 21 Mar 2016
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Tints and Thin-Films to Reduce Headache Frequency in Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT02720211
- Acronym / sponsor ID
- IRB #86498
- Conditions
- Headache Migraine Chronic
- Keywords
- headache, photophobia, migraine, light sensitivity, tints, thin films
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too difficult to enroll according to inclusion/exclusion criteria
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Axon Optics, LLC, Mayo Clinic, Brigham and Women's Hospital, Northwell Health
- Study start
- Aug 2016 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 29 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gray tinted spectacle lenses | Active comparator | Device: Gray tinted spectacle lensesSubjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally |
| Thin-Film spectacle lenses | Experimental | Device: Thin-Film spectacle lensesSubjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gray tinted spectacle lensesA neutral gray optical tint designed to block all wavelengths in the visible spectrum | Device | Gray tinted spectacle lenses |
| Thin-Film spectacle lensesA thin film optical notch filter designed to block 480-nm light in the visible spectrum | Device | Thin-Film spectacle lenses |
Primary outcome
Headache Frequency
Time frame: one month
average number of days (in one month) with at least one headache lasting at least 4 hours
1 secondary outcome
Headache Impact
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Katz, MD principal investigator
Axon Optics, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gray tinted spectacle lenses and Thin-Film spectacle lenses in people with Headache Migraine Chronic, run by University of Utah at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Frequency (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.