Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902496
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Avulux, Inc.

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE March 18, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Headache Impact Test (HIT-6) total score [ Time Frame: Three-week ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Headache Impact Test (HIT-6) total score [ Time Frame: Three-week ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Number and Severity of Headache Days [ Time Frame: Three-week ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 3, 2019)
  • Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention [ Time Frame: Three-week ]
    Compare initial vs. final HIT-6 scores for each treatment period
  • Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention [ Time Frame: Three-week ]
    Compare initial vs. final HIT-6 scores for each treatment period
  • Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention [ Time Frame: Three-week ]
    Compare diaries for treatment vs. control periods to determine proportion of headaches resolved by device vs. device plus medication
  • Proportion of days with light sensitivity over the 3-week intervention [ Time Frame: Three-week ]
    Compare diaries for treatment vs. control periods to determine differences in days with light sensitivity.
  • Average Number of Hours Slept over the 3-week intervention [ Time Frame: Three-week ]
    Compare diaries for treatment vs. control periods to determine whether a significant difference exists in number of hours slept between treatment groups.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.
Official Title  ICMJE Optical Treatment of Migraines Clinical Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Other: HIT-6 Questionnaire
    Headache Impact Test
  • Device: Avulux Spectacles
    Avulux™ Optical Filter in the Form of Spectacle Lenses
  • Device: Sham Spectacles
    Sham
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: HIT-6 Questionnaire
    • Device: Avulux Spectacles
  • 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.
    Interventions:
    • Other: HIT-6 Questionnaire
    • Device: Sham Spectacles
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
50
Actual Study Completion Date  ICMJE May 17, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03902496
Other Study ID Numbers  ICMJE 20190592
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avulux, Inc.
Study Sponsor  ICMJE Avulux, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avulux, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP