Trial Outcomes & Findings for Effect of Blue Light Filtration on Visual Performance (NCT NCT01938989)

Results Overview

Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

158 participants

Primary outcome timeframe

Day 1

Results posted on

2015-01-19

Participant Flow

Participants were recruited from 6 study sites located in the US.

Of the 158 enrolled, 2 participants were exited as screen failures prior to randomization. This reporting group includes all randomized and treated participants (154). Note: 2 participants were randomized but not treated.

Participant milestones

Participant milestones
Measure	Clear, Then Blue Light Filter Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction	Blue Light Filter, Then Clear Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
Overall Study STARTED	77	77
Overall Study COMPLETED	77	77
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Blue Light Filtration on Visual Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=156 Participants Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
Age, Continuous	69.9 years STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: This analysis population includes all participants with observation minus any major protocol deviations.

Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.

Outcome measures

Outcome measures
Measure	Blue Light Filter n=145 Participants Blue light filter clip-on glasses worn over habitual correction	Clear n=144 Participants Clear clip-on glasses worn over habitual correction
Photostress Recovery Time	5.66 seconds Standard Deviation 6.20	6.94 seconds Standard Deviation 7.16

Adverse Events

Blue Light Filter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clear

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

Melvin Sarayba, Franchise Head Cataract, GMA

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER