Trial Outcomes & Findings for Spectacle Tints and Thin-Films for Migraine (NCT NCT02720211)

Results Overview

average number of days (in one month) with at least one headache lasting at least 4 hours

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

one month

Results posted on

2022-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Gray Tinted Spectacle Lenses Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally	Thin-Film Spectacle Lenses Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gray Tinted Spectacle Lenses n=5 Participants Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally Thin-Film spectacle lenses: A thin film optical notch filter designed to block 480-nm light in the visible spectrum	Thin-Film Spectacle Lenses n=5 Participants Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength Gray tinted spectacle lenses: A neutral gray optical tint designed to block all wavelengths in the visible spectrum	Total n=10 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	40 years n=5 Participants	40 years n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=5 Participants	8 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=5 Participants	2 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=5 Participants	10 participants n=10 Participants

PRIMARY outcome

Timeframe: one month

average number of days (in one month) with at least one headache lasting at least 4 hours

Outcome measures

Outcome measures
Measure	Gray Tinted Spectacle Lenses n=5 Participants Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally Thin-Film spectacle lenses: A thin film optical notch filter designed to block 480-nm light in the visible spectrum	Thin-Film Spectacle Lenses n=5 Participants Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength Gray tinted spectacle lenses: A neutral gray optical tint designed to block all wavelengths in the visible spectrum
Headache Frequency	12 days Standard Error 1.0	15 days Standard Error 1.5

SECONDARY outcome

Timeframe: one month

Headache impact as measured by the headache impact test (HIT-6) HIT-6 total score range between 36 and 78, with larger scores reflecting greater impact Scores less than or equal to 49 = Little or no impact Scores between 50 and 55 = Some impact Scores between 56 and 59 = Substantial impact Scores 60 or great = Severe impact

Outcome measures

Outcome measures
Measure	Gray Tinted Spectacle Lenses n=5 Participants Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally Thin-Film spectacle lenses: A thin film optical notch filter designed to block 480-nm light in the visible spectrum	Thin-Film Spectacle Lenses n=5 Participants Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength Gray tinted spectacle lenses: A neutral gray optical tint designed to block all wavelengths in the visible spectrum
Headache Impact	50 score on a scale Standard Deviation 5	55 score on a scale Standard Deviation 5

Adverse Events

Gray Tinted Spectacle Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Thin-Film Spectacle Lenses

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

Director of Clinical Trials

Axon Optics

Phone: 8012304851

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place