Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

Official Title
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Delefilcon A Multifocal Plus Power Lens Design Evaluation

Conditions
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Presbyopia, Hyperopia, Refractive Error

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with normal eyes who are not using any ocular medication. Must sign the Informed Consent document. Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)). Manifest cylinder less than or equal to 0.75D. Best corrected distance VA greater than or equal to 20/25 in each eye. Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week. Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular disease, inflammation, or abnormality that contraindicates CL wear. Any use of systemic or ocular medications for which CL wear could be contraindicated. History of herpetic keratitis. History of refractive surgery or irregular cornea. A clinically significant dry eye that precludes CL wear. Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days. Monocular (only 1 eye with functional vision). History of intolerance or hypersensitivity to any component of the test articles. 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

Primary Purpose: Treatment
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 first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. | Device: Delefilcon A multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use<br>Device: Lotrafilcon B multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement<br>* Other names: AIR OPTIX® AQUA MULTIFOCAL;|
| Other: AOAMF, then Delefilcon A MF<br>Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. | Device: Delefilcon A multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use<br>Device: Lotrafilcon B multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement<br>* Other names: AIR OPTIX® AQUA MULTIFOCAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near | Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | Dispense (Day 1), Hour 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HC/HI Binocular VA at Distance | Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. | Dispense (Day 1), Hour 9 | 
| Over-refraction (OR) Monocular at Distance | OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean. | Dispense (Day 1), Hour 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia