Multifocal Lens Design Evaluation

N/ACompletedNCT01997216

Alcon Research42 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Refractive Error Presbyopia

Interventions

Delefilcon A multifocal contact lensDEVICE

Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Lotrafilcon B multifocal contact lensDEVICE

Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to Hour 9

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to Hour 9

Data from ClinicalTrials.gov

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