Migraine DisordersNCT01828684
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
A study testing Therapeutic Lens Coating in people with Migraine Disorders and Photophobia, run by Bradley Katz at 1 site in United States.
Trial summary
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders, Photophobia
- What is being tested?
- Therapeutic Lens Coating
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be diagnosed with migraine with aura or migraine without aura
- Must have chronic daily migraine (at least 15 headache days per month)
- Age 18 or older
Who cannot join
- Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
- Pregnant
- Unwilling or unable in the judgment of the investigator to complete the study
- Unavailable for any of the study visits
- Light sensitive conditions: meningitis, iritis, blepharospasm
- Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
- Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
- Best corrected visual acuity less than 20/40 in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site
John A Moran Eye Center; University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
About this study
Official title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.
- Conditions
- Migraine Disorders, Photophobia
- Being tested
- Therapeutic Lens Coating, Sham Lens Coating
- Keywords
- Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache
- Medical subject headings
- Migraine Disorders, Photophobia, Migraine with Aura, Migraine without Aura, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Lens CoatingOther
Subjects will wear a therapeutic lens coating for 2 weeks.
Sham Lens CoatingOther
Each subject will wear a sham lens coating for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Lens Coating | Experimental | Subjects will wear a therapeutic lens coating for 2 weeks Receives: Other: Therapeutic Lens Coating; Other: Sham Lens Coating |
| Sham Lens Coating | Sham comparator | Subjects will wear a sham lens coating for 2 weeks Receives: Other: Therapeutic Lens Coating; Other: Sham Lens Coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIT-6
Primary outcome measure is improvement in HIT-6 while wearing therapeutic lenses compared to baseline. The HIT-6 is the Headache Impact Test, a trademarked and copyrighted test (2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies)
Measured: 10 weeks
Secondary outcomes (1)
Headache frequency and severity
Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley Katz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bradley Katz, University of Utah
- Investigators
- Bradley J Katz, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828684
- Sponsor's protocol ID
- IRB_00047263
- Status last verified
- Mar 2016
- First submitted
- 7 Apr 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
- ClinicalTrials.gov ID
- NCT01828684
- Acronym / sponsor ID
- IRB_00047263
- Conditions
- Migraine Disorders, Photophobia
- Keywords
- Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bradley KatzUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Lens Coating | Experimental | Other: Therapeutic Lens Coating, Other: Sham Lens CoatingSubjects will wear a therapeutic lens coating for 2 weeks |
| Sham Lens Coating | Sham comparator | Other: Therapeutic Lens Coating, Other: Sham Lens CoatingSubjects will wear a sham lens coating for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be diagnosed with migraine with aura or migraine without aura
- Must have chronic daily migraine (at least 15 headache days per month)
- Age 18 or older
Key exclusion criteria (8 listed)
- Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
- Pregnant
- Unwilling or unable in the judgment of the investigator to complete the study
- Unavailable for any of the study visits
- Light sensitive conditions: meningitis, iritis, blepharospasm
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 |
|---|---|---|
| Therapeutic Lens CoatingSubjects will wear a therapeutic lens coating for 2 weeks. | Other | Sham Lens Coating, Therapeutic Lens Coating |
| Sham Lens CoatingEach subject will wear a sham lens coating for 2 weeks. | Other | Sham Lens Coating, Therapeutic Lens Coating |
Primary outcome
HIT-6
Time frame: 10 weeks
Primary outcome measure is improvement in HIT-6 while wearing therapeutic lenses compared to baseline. The HIT-6 is the Headache Impact Test, a trademarked and copyrighted test (2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies)
1 secondary outcome
Headache frequency and severity
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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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 J Katz, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Lens Coating in people with Migraine Disorders and Photophobia, run by Bradley Katz at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HIT-6 (time frame: 10 weeks). 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 31 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.