Trial Outcomes & Findings for Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses (NCT NCT02189863)

Results Overview

Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Week 2, each period

Results posted on

2016-02-18

Participant Flow

Subjects were recruited from 2 investigational sites located in the UK.

Of the 33 enrolled, 6 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who successfully tried at least one study lens (27).

Participant milestones

Participant milestones
Measure	AOAMV, Then AOAMF Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2	AOAMF, Then AOAMV Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
First 2 Weeks STARTED	12	15
First 2 Weeks COMPLETED	8	13
First 2 Weeks NOT COMPLETED	4	2
Second 2 Weeks STARTED	8	13
Second 2 Weeks COMPLETED	8	13
Second 2 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AOAMV, Then AOAMF Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2	AOAMF, Then AOAMV Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
First 2 Weeks Motion Sickness	4	2

Baseline Characteristics

Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=27 Participants Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
Age, Continuous	55.4 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2, each period

Population: This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).

Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.

Outcome measures

Outcome measures
Measure	AOAMV n=21 Participants Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks	AOAMF n=21 Participants Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)	1.89 seconds Standard Deviation 0.22	1.88 seconds Standard Deviation 0.19

SECONDARY outcome

Timeframe: Week 2, each period

Population: This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).

The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.