Multifocal Lens Design Evaluation

Multifocal Lens Design Evaluation (US)

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Presbyopia
• Intervention / Treatment: Device: Delefilcon A multifocal contact lens; Device: Lotrafilcon B multifocal contact lens

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delefilcon A MF, then AOAMF; 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.	Device: Delefilcon A multifocal contact lens; Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Device: Lotrafilcon B multifocal contact lens; Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Other Names: AOAMF; AIR OPTIX® AQUA MULTIFOCAL
Other: AOAMF, then Delefilcon A MF; 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.	Device: Delefilcon A multifocal contact lens; Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Device: Lotrafilcon B multifocal contact lens; Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines; Other Names: AOAMF; AIR OPTIX® AQUA MULTIFOCAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular HC/HI Visual Acuity at Near (40 cm)	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.	Up to Hour 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular HC/HI Visual Acuity at Distance	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.	Up to Hour 9
Mean Monocular Over-refraction (OR) at Distance	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.	Up to Hour 9

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Joachim Nick, Dipl.-Ing, Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: contact lenses; multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: C-12-036