Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Optical Treatment of Migraines Clinical Study

The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Other: HIT-6 Questionnaire; Device: Avulux Spectacles; Device: Sham Spectacles

Detailed Description

Avulux™ is intended to decrease the impact of headache and migraine on normal daily life and the ability to function, and reduce the frequency and severity of headache, in adult patients diagnosed with episodic migraine headache or chronic migraine.

Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington-Davis Clinical Research

Participation Criteria

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. Patient is 18 years or older
2. Patient is willing and able to provide written informed consent
3. Patient is willing and able to complete all scheduled study visits

4. Diagnosis of migraine, based on the following primary headache characteristics:

   1. At least 5 attacks fulfilling criteria b-d:
   2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

   3. Headache has at least two of the following characteristics:

      • unilateral location
      • pulsating quality
      • moderate or severe pain intensity
      • aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)

   4. During headache at least one of the following:

      • nausea and/or vomiting
      • photophobia and phonophobia
   5. Not attributed to another disorder

Exclusion Criteria:

1. Patients with other light sensitive conditions, such as iritis.
2. Patients who have less than 4 headache days per month
3. Patients who have chronic daily headaches.
4. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avulux Spectacles; Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.	Other: HIT-6 Questionnaire; Headache Impact Test; Device: Avulux Spectacles; Avulux™ Optical Filter in the Form of Spectacle Lenses
Sham Comparator: Sham Spectacles; Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.	Other: HIT-6 Questionnaire; Headache Impact Test; Device: Sham Spectacles; Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test (HIT-6) total score	The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6) scores at three weeks when compared to a control/sham device. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact.	Three-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Severity of Headache Days	To measure effects on the number and severity of headaches, we will use the subjects' daily diaries to count the number of days with headache that either a) made activity difficult, b) caused activity changes, or c) caused patient to go to bed. We will then compare the proportion of days with headaches that met one of these criteria for the 4-week baseline period and the 3-week intervention.	Three-week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention	Compare initial vs. final HIT-6 scores for each treatment period	Three-week
Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention	Compare initial vs. final HIT-6 scores for each treatment period	Three-week
Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention	Compare diaries for treatment vs. control periods to determine proportion of headaches resolved by device vs. device plus medication	Three-week
Proportion of days with light sensitivity over the 3-week intervention	Compare diaries for treatment vs. control periods to determine differences in days with light sensitivity.	Three-week
Average Number of Hours Slept over the 3-week intervention	Compare diaries for treatment vs. control periods to determine whether a significant difference exists in number of hours slept between treatment groups.	Three-week

Collaborators and Investigators

• Sponsor: Avulux, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 20190592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No