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

Migraine Clinical Trial

Official title:

Optical Treatment of Migraines Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902496
• Other study ID #: 20190592
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: May 17, 2019

Study information

• Verified date: July 2019
• Source: Avulux, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• HIT-6 Questionnaire
Headache Impact Test

Device:
• Avulux Spectacles
Avulux™ Optical Filter in the Form of Spectacle Lenses
• Sham Spectacles
Sham

Locations

Country	Name	City	State
United States	Remington-Davis Clinical Research	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Avulux, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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