Multifocal Lens Design Evaluation

Not Applicable

Completed

• Conditions: Refractive Error; Presbyopia
• Interventions: Device: Delefilcon A multifocal contact lens; Device: Lotrafilcon B multifocal contact lens

• Registration Number: NCT01997216
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

Detailed Description

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Status Verified: 2013-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2013-12-17
• Last Update Submitted: 2013-12-17
• Results First Posted: 2014-02-04
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Sign written Informed Consent document.
• Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
• Be presbyopic with a spectacle add ≥ 0.50 diopter.
• Currently wearing soft contact lenses at least 5 days a week.
• Other protocol-specified inclusion criteria may apply

Exclusion Criteria

• Eye injury or surgery within 12 weeks of enrollment in this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
• Binocular visual acuity worse than 20/25.
• Corrected by monovision.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Delefilcon A MF, then AOAMF	Delefilcon A multifocal contact lens	Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
Delefilcon A MF, then AOAMF	Lotrafilcon B multifocal contact lens	Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
AOAMF, then Delefilcon A MF	Delefilcon A multifocal contact lens	Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
AOAMF, then Delefilcon A MF	Lotrafilcon B multifocal contact lens	Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.

Primary Outcome Measures

Name	Time	Method
Mean Binocular HC/HI Visual Acuity at Near (40 cm)	Up to Hour 9	The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Mean Binocular HC/HI Visual Acuity at Distance	Up to Hour 9	The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Mean Monocular Over-refraction (OR) at Distance	Up to Hour 9	OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.