Spectacle Tints and Thin-Films for Migraine

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Bradley Katz, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Utah

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

Nearly all migraine sufferers report sensitivity to light during a headache and a significant proportion of sufferers report light sensitivity between attacks. Light is also a common trigger for migraine headaches. Spectacle lenses that have been treated with tints and spectacle lenses that have been treated with thin-films have both been shown to reduce light sensitivity and headache in patients with migraine. At this time, it is not clear which spectacle lens treatment is superior. The purpose of this trial is to determine if there's a significant, therapeutic advantage to either spectacle lens treatment. Both treatments could be a novel, non-invasive adjuvant in the treatment of migraine.

Research Team

Bradley Katz, MD

Principal Investigator

Axon Optics, LLC

Eligibility Criteria

Inclusion Criteria

Subjects must meet the International Headache Society criteria for chronic migraine (International Classification of Headache Disorders, 3rd edition (Headache Classification Committee of the International Headache Society, 2013). All subjects must be between the ages of 18 and 60 years-old.

To be included in the study, in the best judgment of the investigator, subjects must be stable on their current migraine treatment regimen. Stability is defined as no major changes in therapy contemplated within the next 4 months.

Treatment Details

Interventions

• Gray tinted spectacle lenses (Behavioural Intervention)
• Thin-Film spectacle lenses (Behavioural Intervention)

Participant Groups

Group I: Thin-Film spectacle lenses Experimental Treatment 2 Interventions

Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength

Group II: Gray tinted spectacle lenses Active Control 2 Interventions

Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Axon Optics, LLC

Industry Sponsor

Trials

1

Recruited

10+

Axon Optics, LLC

Collaborator

Trials

1

Recruited

10+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine