Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Delefilcon A Multifocal Plus Power Lens Design Evaluation

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).

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.