NCT01828684

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

April 7, 2013

Last Update Submit

March 30, 2016

Conditions

Migraine DisordersPhotophobia

Keywords

Migraine with AuraMigraine without AuraPhotophobiaChronic Daily Headache

Outcome Measures

Primary Outcomes (1)

  • 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)

    10 weeks

Secondary Outcomes (1)

  • Headache frequency and severity

    10 weeks

Other Outcomes (1)

  • Photophobia

    10 weeks

Study Arms (2)

Therapeutic Lens Coating

EXPERIMENTAL

Subjects will wear a therapeutic lens coating for 2 weeks

Other: Therapeutic Lens CoatingOther: Sham Lens Coating

Sham Lens Coating

SHAM COMPARATOR

Subjects will wear a sham lens coating for 2 weeks

Other: Therapeutic Lens CoatingOther: Sham Lens Coating

Interventions

Therapeutic Lens CoatingOTHER

Subjects will wear a therapeutic lens coating for 2 weeks.

Sham Lens CoatingTherapeutic Lens Coating
Sham Lens CoatingOTHER

Each subject will wear a sham lens coating for 2 weeks.

Sham Lens CoatingTherapeutic Lens Coating

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Migraine DisordersPhotophobiaMigraine with AuraMigraine without AuraHeadache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bradley J Katz, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Ophthalmology & Neurology

Study Record Dates

First Submitted

April 7, 2013

First Posted

April 11, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(1)