Trial Outcomes & Findings for Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine (NCT NCT01942486)

NCT ID: NCT01942486

Last Updated: 2022-11-09

Results Overview

The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-11-09

Participant Flow

Participant milestones

Measure	Investigational Coating Subjects will wear an investigational coating on their glasses
Overall Study STARTED	35
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Investigational Coating Subjects will wear an investigational coating on their glasses
Overall Study Lost to Follow-up	27

Baseline Characteristics

Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

Baseline characteristics by cohort

Measure	Investigational Coating n=35 Participants Investigational Coating
Age, Categorical <=18 years	35 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	13 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Only subjects that completed the trial were analyzed

The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.

Outcome measures

Measure	Investigational Coating n=8 Participants Subjects will wear an investigational coating on their eyeglasses to reduce headache frequency
HIT-6 Score	62.3 units on a scale Standard Deviation 4.8

Adverse Events

Investigational Coating

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bradley Katz

University of Utah

Phone: 8015871079

Email: bradley.katz@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place