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

March 30, 2016 updated by: Bradley Katz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks
Other: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.
Other: Sham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.
SHAM_COMPARATOR: Sham Lens Coating
Subjects will wear a sham lens coating for 2 weeks
Other: Therapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.
Other: Sham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache frequency and severity
Time Frame: 10 weeks
Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries.
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photophobia
Time Frame: 10 weeks
Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bradley Katz

Investigators

  • Principal Investigator: Bradley J Katz, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00047263

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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