CClinicalTrials.gg
CompletedNCT01828684Updated Mar 31, 2016

Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine

An interventional study of Therapeutic Lens Coating and Sham Lens Coating in Migraine Disorders and Photophobia, sponsored by Bradley Katz. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Bradley Katz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine Disorders
  • Photophobia

Keywords

  • Migraine with Aura
  • Migraine without Aura
  • Photophobia
  • Chronic Daily Headache
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Must be diagnosed with migraine with aura or migraine without aura
  2. Must have chronic daily migraine (at least 15 headache days per month)
  3. Age 18 or older

Exclusion criteria

Exclusion Criteria:

  1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
  2. Pregnant
  3. Unwilling or unable in the judgment of the investigator to complete the study
  4. Unavailable for any of the study visits
  5. Light sensitive conditions: meningitis, iritis, blepharospasm
  6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
  7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
  8. Best corrected visual acuity less than 20/40 in either eye
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Therapeutic Lens Coating

    Subjects will wear a therapeutic lens coating for 2 weeks

    Other: Therapeutic Lens Coating · Other: Sham Lens Coating

  • Sham comparator
    Sham Lens Coating

    Subjects will wear a sham lens coating for 2 weeks

    Other: Therapeutic Lens Coating · Other: Sham Lens Coating

Interventions

  • OtherTherapeutic Lens Coating

    Subjects will wear a therapeutic lens coating for 2 weeks.

  • OtherSham Lens Coating

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

05

What researchers measure

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)

    Time frame: 10 weeks

Secondary outcomes

  1. Headache frequency and severity

    Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.

    Time frame: 10 weeks

Other outcomes

  1. Photophobia

    Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.

    Time frame: 10 weeks

06

Study locations

1 site
  • John A Moran Eye Center; University of Utah Hospitals and Clinics
    Salt Lake City, Utah 84132, United States
07

Registry details

Key details

Study ID
NCT01828684
Lead sponsor
Bradley Katz
Responsible party
Bradley Katz (Associate Professor of Ophthalmology & Neurology, University of Utah) — Sponsor-investigator
First posted
Apr 11, 2013
Start date
Mar 2013
Primary completion
Jan 2014
Completion
Feb 2014
Last update
Mar 31, 2016

Study contacts

Bradley J Katz, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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