MigraineCOMFORTNCT06161129
Filter Lenses for the Prevention of Migraine Attacks
A study testing Lenses in people with Migraine and Glasses, run by Rune Skovgaard Rasmussen at 1 site in Denmark.
Trial summary
The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult individuals below the age of 66.
- Diagnosed with migraine by a neurologist.
- Able to communicate in Danish
- Able to voluntarily come to the clinic during an untreated migraine attack.
- Must have had migraine attacks for more than 1 year.
Who cannot join
- Fewer than four migraine attacks per month.
- Chronic neck pain
- Chronic headache
- Chronic use of opioids
- Presence of a pathological eye condition (in the study, an eye condition is defined as a permanent eye condition that affects the front and back of the eye, such as glaucoma, age-related macular degeneration)
- Other acquired and congenital retinal diseases must not be present.
- If there is more than 1 line of deviation on the Snellen chart from habitual correction to best correction, the participant must have a new pair of glasses made at their own expense.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
CSU-Slagelse
Slagelse, 4200
Peter Smaakjær, MSc, 58575769, pesma@slagelse.dk
Rune S Rasmussen, 28757500, rsras@slagelse.dk
About this study
Official title: Filter Lenses for the Prevention of Migraine Attacks - Effects of Blue Cut and FL-41 Filter Lenses
The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.
Read the detailed description
Migraine is a neurological disorder that often causes severe, throbbing headaches that can be accompanied by nausea and vomiting. In addition, sound or light sensitivity is often seen. An attack can last up to 72 hours. Migraine can occur in one half of the head and is exacerbated by physical activity. There are several different types of migraine, of which the inherited migraine typically cannot be cured. Migraine affects about 15% of all adults worldwide, but about twice as many women as men.
About 10% of diagnosed patients have chronic migraine, which is characterized by at least 15 days of severe headache each month. Many patients have tension headaches between attacks.
Migraine most often starts in the most productive years of life, between the ages of 20 and 50, and most affects the age group of 35-54 years. For many women, migraine debuts after childbirth, while others experience that it disappears after childbirth. Several women experience that they get migraine when they have their period. This migraine is called hormonal and can follow them for many years.
Several studies have shown that migraine attacks are triggered by light, and many become very light-sensitive during an attack. So far, a FL 41 lens, which excludes blue-green light, has been the only migraine-specific optical treatment.
A new lens called "Blue Cut for Night Glass" has in a study resulted in participants experiencing less migraine. For 4 weeks, 10 participants used only the lens in the evening. Results showed that they had fewer days with headaches. The lens is so new that it has not yet come into regular production and trade. In connection with the present study, the investigators have received 13 sets of lenses.
For many years, FL-41 has been the preferred filter lens for the prevention of migraine attacks, since it was first successfully tested on children in 1991. Since this study, much has happened in terms of the development of filter lenses.
The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.
- Conditions
- Migraine, Glasses, Headache, Visual Impairment
- Being tested
- Lenses
- Keywords
- Migraine, filter glasses, pain, headache, treatment
- Medical subject headings
- Migraine Disorders, Headache, Vision Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensesDevice
The filter lenses will be worn by participants for one month all day.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group of 50 participants (control) will receive glasses with clear lenses. |
| FL-41 | Active comparator | Group of 50 participants will receive a glasses with an FL-41 filter. Receives: Device: Lenses |
| BlueCut | Active comparator | Group of 50 participants will receive glasses with a Blue Cut filter. Receives: Device: Lenses |
| 500nm | Active comparator | Group of 50 participants will receive glasses with a below 500 nm filter Receives: Device: Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain intensity during migraine attacks
Intensity is described from 1-10 on a visual analog pain scale (VAS). A score of 1 is very mild intensity and 10 is very severe.
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Secondary outcomes (10)
Headache Impact Test (HIT-6)
Headache Impact Test (HIT-6), which is a validated questionnaire. It consists of 6 questions and assesses participants' functional status in the past 4 weeks. The questions measure the frequency and severity of headaches, as well as their consequences for the participant's activity level. The scale scores from 36 to 78, with a high score being the worst. This questionnaire is recommended by the Danish Medicines Council for Danish migraine patients
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Migraine-Specific Quality-of-Life Questionnaire v. 2.1 (MSQ)
MSQ is a frequently used disease-specific survey for assessing health-related quality of life in people with migraine. MSQ is validated for persons with episodic migraine and persons with chronic migraine. MSQ measures quality of life within the last 4 weeks in relation to restrictive function, preventive function, and emotional function. The score ranges from 0-100, with a higher score indicating improvement in quality of life
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Monthly migraine days
The date of the migraine attack, duration, and medication used are noted. A migraine day is defined as a day on which the person experienced a migraine attack or used medication to relieve acute attacks
Measured: Every day of participation lasting 8 weeks
Fatigue Severity Scale
Short fatigue questionnaire used to assess the occurrence of disabling fatigue. There are 9 items scored from 1 to 7, where 7 indicated the most fatigue. A score of 63 is worst, and disabling fatigue may be observed scoring 45 or more points.
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Groffman Visual Tracing Test
Test for assessment of attention, visuospatial function, and figure-ground perception. The test is stressful and requires a high degree of sustained visual focus, and can be expected to be affected by pain, fatigue, light sensitivity, and oculomotor dysfunction
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The Migraine Disability Assessment Test
The questionnaire is changed to a 1-month focus period instead of 3 months. The Migraine Disability Assessment Test is frequently used to measure the effectiveness of interventions for migraine
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Medication use, both as needed (PN) and daily fixed medication
Consumption of preparations and dosage is recorded in a diary
Measured: Every day of participation lasting 8 weeks
Major Depression Inventory
About 80% of people with chronic migraine are affected by depression. Major Depression Inventory is used in the present study to monitor for symptoms of depression as well as part of the assessment of mental well-being and quality of life
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The 36-Item Health Survey
The 36-Item Health Survey is used to measure quality of life and is frequently used to measure the effectiveness of different treatments for headache-affected persons. The questionnaire has 8 dimensions ranging for 0 to 100 points, where a high score indicates better functioning. The 8 dimensions are: physical functioning, role physical, bodily pain, general health perceptions, vitality, social function, role emotional, og mental health.
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Assessment of photophobia via questionnaire
Assessment of photophobia via questionnaire, where each participant assesses their own light sensitivity during the day, at night, and indoors. This is done both with and without filter glasses. The amount of photophobia is measured on a scale from 0 to 10, where 10 indicates maximum and worst photophobia.
Measured: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Model description
- Four arms will be used: 1: Control. 2. BlueCut filter. 3. FL-41 filter. 4. Below 500 nm filter.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rune Skovgaard Rasmussen
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Communication (CSU-Slagelse)
- Responsible party
- Sponsor-investigator, Rune Skovgaard Rasmussen, University Hospital, Gentofte, Copenhagen
- Investigators
- Peter Smaakjær, MSc, Principal investigator, CSU-Slagelse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161129
- Sponsor's protocol ID
- 108314
- Acronym
- COMFORT
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filter Lenses for the Prevention of Migraine Attacks - Effects of Blue Cut and FL-41 Filter Lenses
- ClinicalTrials.gov ID
- NCT06161129
- Acronym / sponsor ID
- COMFORT / 108314
- Conditions
- Migraine, Glasses, Headache, Visual Impairment
- Keywords
- Migraine, filter glasses, pain, headache, treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rune Skovgaard RasmussenUniversity, hospital or other
- Collaborators
- Center of Communication (CSU-Slagelse)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 7 Dec 2023 (actual)
- 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.
The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.
Detailed description
Migraine is a neurological disorder that often causes severe, throbbing headaches that can be accompanied by nausea and vomiting. In addition, sound or light sensitivity is often seen. An attack can last up to 72 hours. Migraine can occur in one half of the head and is exacerbated by physical activity. There are several different types of migraine, of which the inherited migraine typically cannot be cured. Migraine affects about 15% of all adults worldwide, but about twice as many women as men.
About 10% of diagnosed patients have chronic migraine, which is characterized by at least 15 days of severe headache each month. Many patients have tension headaches between attacks.
Migraine most often starts in the most productive years of life, between the ages of 20 and 50, and most affects the age group of 35-54 years. For many women, migraine debuts after childbirth, while others experience that it disappears after childbirth. Several women experience that they get migraine when they have their period. This migraine is called hormonal and can follow them for many years.
Several studies have shown that migraine attacks are triggered by light, and many become very light-sensitive during an attack. So far, a FL 41 lens, which excludes blue-green light, has been the only migraine-specific optical treatment.
A new lens called "Blue Cut for Night Glass" has in a study resulted in participants experiencing less migraine. For 4 weeks, 10 participants used only the lens in the evening. Results showed that they had fewer days with headaches. The lens is so new that it has not yet come into regular production and trade. In connection with the present study, the investigators have received 13 sets of lenses.
For many years, FL-41 has been the preferred filter lens for the prevention of migraine attacks, since it was first successfully tested on children in 1991. Since this study, much has happened in terms of the development of filter lenses.
The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Four arms will be used: 1: Control. 2. BlueCut filter. 3. FL-41 filter. 4. Below 500 nm filter.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group of 50 participants (control) will receive glasses with clear lenses. |
| FL-41 | Active comparator | Device: LensesGroup of 50 participants will receive a glasses with an FL-41 filter. |
| BlueCut | Active comparator | Device: LensesGroup of 50 participants will receive glasses with a Blue Cut filter. |
| 500nm | Active comparator | Device: LensesGroup of 50 participants will receive glasses with a below 500 nm filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult individuals below the age of 66.
- Diagnosed with migraine by a neurologist.
- Able to communicate in Danish
- Able to voluntarily come to the clinic during an untreated migraine attack.
- Must have had migraine attacks for more than 1 year.
Key exclusion criteria (7 listed)
- Fewer than four migraine attacks per month.
- Chronic neck pain
- Chronic headache
- Chronic use of opioids
- Presence of a pathological eye condition (in the study, an eye condition is defined as a permanent eye condition that affects the front and back of the eye, such as glaucoma, age-related macular degeneration)
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 |
|---|---|---|
| LensesThe filter lenses will be worn by participants for one month all day. | Device | 500nm, BlueCut, FL-41 |
Primary outcome
Change of pain intensity during migraine attacks
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Intensity is described from 1-10 on a visual analog pain scale (VAS). A score of 1 is very mild intensity and 10 is very severe.
10 secondary outcomes
Headache Impact Test (HIT-6)
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Migraine-Specific Quality-of-Life Questionnaire v. 2.1 (MSQ)
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Monthly migraine days
Time frame: Every day of participation lasting 8 weeks
Fatigue Severity Scale
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Groffman Visual Tracing Test
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The Migraine Disability Assessment Test
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Medication use, both as needed (PN) and daily fixed medication
Time frame: Every day of participation lasting 8 weeks
Major Depression Inventory
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The 36-Item Health Survey
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Assessment of photophobia via questionnaire
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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.
Peter Smaakjær, MSc principal investigator
CSU-Slagelse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenses in people with Migraine and Glasses, run by Rune Skovgaard Rasmussen at 1 site in Denmark.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Smaakjær (+45 58575769, pesma@slagelse.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity during migraine attacks (time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion). 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 9 Dec 2024.