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

• ClinicalTrials.gov Identifier: NCT01828684
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: March 31, 2016
• Sponsor: Bradley Katz
• Information provided by (Responsible Party): Bradley Katz, University of Utah

Tracking Information

• First Submitted Date: April 7, 2013
• First Posted Date: April 11, 2013
• Last Update Posted Date: March 31, 2016
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2013)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 10, 2013)

Headache frequency and severity [ Time Frame: 10 weeks ]

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 10, 2013)

Photophobia [ Time Frame: 10 weeks ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
• Official Title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Migraine Disorders
• Photophobia

Intervention

• 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.

Study Arms

• Experimental: Therapeutic Lens Coating
  Subjects will wear a therapeutic lens coating for 2 weeks
  Interventions:

  • Other: Therapeutic Lens Coating
  • Other: Sham Lens Coating
• Sham Comparator: Sham Lens Coating
  Subjects will wear a sham lens coating for 2 weeks
  Interventions:

  • Other: Therapeutic Lens Coating
  • Other: Sham Lens Coating

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2014): 48
• Original Estimated Enrollment (submitted: April 10, 2013): 50
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01828684
• Other Study ID Numbers: IRB_00047263
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bradley Katz, University of Utah
• Study Sponsor: Bradley Katz
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Utah
• Verification Date: March 2016