search
Back to results

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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIT-6 Questionnaire
Avulux Spectacles
Sham Spectacles
Sponsored by
Avulux, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Remington-Davis Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Avulux Spectacles

Sham Spectacles

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 2, 2019
Last Updated
July 2, 2019
Sponsor
Avulux, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03902496
Brief Title
Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.
Official Title
Optical Treatment of Migraines Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avulux, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A total of 50 subjects will be randomized into one of two treatment groups in a one-to-one ratio. After three weeks, and following a one-week washout period, subjects will be given spectacles from the other treatment group
Masking
ParticipantCare ProviderInvestigator
Masking Description
The active and sham lenses will have tints calibrated such that the optical density, that is the overall "darkness" of all study lenses, will be the same. All study lenses will appear to have the same overall light-blocking effect to study subjects.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avulux Spectacles
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Spectacles
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HIT-6 Questionnaire
Intervention Description
Headache Impact Test
Intervention Type
Device
Intervention Name(s)
Avulux Spectacles
Intervention Description
Avulux™ Optical Filter in the Form of Spectacle Lenses
Intervention Type
Device
Intervention Name(s)
Sham Spectacles
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Headache Impact Test (HIT-6) total score
Description
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.
Time Frame
Three-week
Secondary Outcome Measure Information:
Title
Number and Severity of Headache Days
Description
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.
Time Frame
Three-week
Other Pre-specified Outcome Measures:
Title
Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention
Description
Compare initial vs. final HIT-6 scores for each treatment period
Time Frame
Three-week
Title
Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention
Description
Compare initial vs. final HIT-6 scores for each treatment period
Time Frame
Three-week
Title
Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention
Description
Compare diaries for treatment vs. control periods to determine proportion of headaches resolved by device vs. device plus medication
Time Frame
Three-week
Title
Proportion of days with light sensitivity over the 3-week intervention
Description
Compare diaries for treatment vs. control periods to determine differences in days with light sensitivity.
Time Frame
Three-week
Title
Average Number of Hours Slept over the 3-week intervention
Description
Compare diaries for treatment vs. control periods to determine whether a significant difference exists in number of hours slept between treatment groups.
Time Frame
Three-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 years or older Patient is willing and able to provide written informed consent Patient is willing and able to complete all scheduled study visits Diagnosis of migraine, based on the following primary headache characteristics: At least 5 attacks fulfilling criteria b-d: Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) 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) During headache at least one of the following: nausea and/or vomiting photophobia and phonophobia Not attributed to another disorder Exclusion Criteria: Patients with other light sensitive conditions, such as iritis. Patients who have less than 4 headache days per month Patients who have chronic daily headaches. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.
Facility Information:
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs