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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189863
• Other study ID #: M-14-009
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: January 21, 2016
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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 (8? exophoria, =8? esophoria), vertical phoria = 1.5? 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
• Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
• Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
• Comfilcon A MF
Multifocal contact lenses worn in both eyes
• Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)	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.	Week 2, each period	No
Secondary	Standard Deviation of Lateral Positioning	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.	Week 2, each period	No