Multifocal Lens Design Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multifocal Lens Design Evaluation (US)

Conditions
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Refractive Error, Presbyopia

Intervention / Treatment
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* Device: Delefilcon A multifocal contact lens
* Device: Lotrafilcon B multifocal contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, multifocal