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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02189863
• Collaborator: (none)
• Enrollment: 33
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The overall objective of this study is to compare the effect on simulated driving performance of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Lotrafilcon B MF; Device: Lotrafilcon B MV; Device: Lotrafilcon B SVD; Device: Comfilcon A MF; Device: Habitual contact lenses	N/A

Detailed Description

In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF) soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a standardised driving simulation for each of the two treatments. A fresh pair of lenses was dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD) and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional same-day assessment. Habitual correction was worn for an acclimatization drive in the driving simulator during Period 1.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Official Title: Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: AOAMV, then AOAMF Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2	Device: Lotrafilcon B MF; Multifocal contact lenses worn in both eyes; Other Names: AIR OPTIX® Aqua Multifocal AOAMF ; Device: Lotrafilcon B MV; Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near; Other Names: AIR OPTIX® Aqua AOAMV ; Device: Lotrafilcon B SVD; Spherical contact lenses worn with both eyes corrected for distance; Other Names: AIR OPTIX® Aqua ; Device: Comfilcon A MF; Multifocal contact lenses worn in both eyes; Other Names: Biofinity® Multifocal ; Device: Habitual contact lenses; Contact lenses worn in both eyes per subject's habitual prescription
Other: 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	Device: Lotrafilcon B MF; Multifocal contact lenses worn in both eyes; Other Names: AIR OPTIX® Aqua Multifocal AOAMF ; Device: Lotrafilcon B MV; Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near; Other Names: AIR OPTIX® Aqua AOAMV ; Device: Lotrafilcon B SVD; Spherical contact lenses worn with both eyes corrected for distance; Other Names: AIR OPTIX® Aqua ; Device: Comfilcon A MF; Multifocal contact lenses worn in both eyes; Other Names: Biofinity® Multifocal ; Device: Habitual contact lenses; Contact lenses worn in both eyes per subject's habitual prescription

Outcome Measures

Primary Outcome Measures

1. Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) [Week 2, each period]

   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.

Secondary Outcome Measures

1. Standard Deviation of Lateral Positioning [Week 2, each period]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Current soft contact lens wearers (for 1 month or more) with distance spherical power requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -10.00D, and who have never tried and then failed in monovision or AOAMF.

• Medium to high presbyopia, i.e. spectacle add requirement of +1.50D or more.

• Astigmatism, if present, ≤1.00D in both eyes.

• Distance visual acuity (VA) correctable to 20/30 (+0.2 logMAR) in both eyes.

• Within the normal ranges for binocular vision for distance (8Δ exophoria, ≤8Δ esophoria), vertical phoria = 1.5Δ hypo or hyper.

• Full United Kingdom driving license held for at least 3 years, with at least 2000 miles driven per year.

• Willing to wear study lenses at least 5 days per week.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Existing AIR OPTIX® Multifocal CL user.

• Sphere requirement in the range +0.75 to -0.75D in both eyes.

• Previous refractive surgery.

• Ocular/systemic medical condition or medical treatment contra-indicating contact lens wear or driving simulation.

• Participation in a clinical study within the past 30 days.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, Global Medical Affairs, Vision Care, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02189863
• Other Study ID Numbers: M-14-009
• First Posted: Jul 15, 2014
• Last Update Posted: Feb 18, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Alcon Research: Driving Simulator; Air Optix Aqua; AOAMF
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 2 investigational sites located in the UK.
Pre-assignment Detail	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).

Arm/Group Title	AOAMV, Then AOAMF	AOAMF, Then AOAMV
Arm/Group Description	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	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
Period Title: First 2 Weeks
STARTED	12	15
COMPLETED	8	13
NOT COMPLETED	4	2
Period Title: First 2 Weeks
STARTED	8	13
COMPLETED	8	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (5.4)
Sex: Female, Male (Count of Participants)
Female	17 63%
Male	10 37%

Outcome Measures

1. Primary Outcome

Title	Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)
Description	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.
Time Frame	Week 2, each period

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	AOAMV	AOAMF
Arm/Group Description	Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks	Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
Measure Participants	21	21
Mean (Standard Deviation) [seconds]	1.89 (0.22)	1.88 (0.19)

2. Secondary Outcome

Title	Standard Deviation of Lateral Positioning
Description	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.
Time Frame	Week 2, each period

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	AOAMV	AOAMF
Arm/Group Description	Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks	Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
Measure Participants	21	21
Mean (Standard Deviation) [meters]	0.35 (0.06)	0.35 (0.05)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 4 weeks). This analysis group includes all randomized subjects who successfully tried at least one study lens, based on treatment-specific exposure.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular adverse events are presented for both study eye and non-study eye.
Arm/Group Title	AOAMV		AOAMF		Lotra B SVD		Biofinity MF		Habitual
Arm/Group Description	Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks		Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks		Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment		Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment		Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
All Cause Mortality
	AOAMV		AOAMF		Lotra B SVD		Biofinity MF		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AOAMV		AOAMF		Lotra B SVD		Biofinity MF		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)		0/23 (0%)		0/21 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	AOAMV		AOAMF		Lotra B SVD		Biofinity MF		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		1/23 (4.3%)		2/23 (8.7%)		0/21 (0%)		2/27 (7.4%)
General disorders
Motion sickness	1/25 (4%)		1/23 (4.3%)		2/23 (8.7%)		0/21 (0%)		2/27 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.