NCT06161129

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Feb 2029

First Submitted

Initial submission to the registry

November 16, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

November 16, 2023

Last Update Submit

December 4, 2024

Conditions

MigraineGlassesHeadacheVisual Impairment

Keywords

Migrainefilter glassespainheadachetreatment

Outcome Measures

Primary Outcomes (1)

  • 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 at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion

Secondary Outcomes (10)

  • Headache Impact Test (HIT-6)

    Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion

  • Migraine-Specific Quality-of-Life Questionnaire v. 2.1 (MSQ)

    Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion

  • Monthly migraine days

    Every day of participation lasting 8 weeks

  • Fatigue Severity Scale

    Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion

  • Groffman Visual Tracing Test

    Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion

  • +5 more secondary outcomes

Study Arms (4)

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.

Device: Lenses

BlueCut

ACTIVE COMPARATOR

Group of 50 participants will receive glasses with a Blue Cut filter.

Device: Lenses

500nm

ACTIVE COMPARATOR

Group of 50 participants will receive glasses with a below 500 nm filter

Device: Lenses

Interventions

LensesDEVICE

The filter lenses will be worn by participants for one month all day.

500nmBlueCutFL-41

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSU-Slagelse

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Migraine DisordersHeadacheVision DisordersPain

Interventions

Lenses

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersEye Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and Supplies

Study Officials

  • Peter Smaakjær, MSc

    CSU-Slagelse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Smaakjær

CONTACT

+45 58575769pesma@slagelse.dk

Rune S Rasmussen

CONTACT

+45 28757500rsras@slagelse.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not meet each other. Outcome assessors and participants will not know which type of filters are used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Four arms will be used: 1: Control. 2. BlueCut filter. 3. FL-41 filter. 4. Below 500 nm filter.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of pathology, neuropsychologist

Study Record Dates

First Submitted

November 16, 2023

First Posted

December 7, 2023

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)