Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.

Inclusion Criteria:

• Sign Informed Consent Document.
• Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
• Currently wear soft contact lenses.
• Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
• Manifest cylinder less than or equal to 1.00 D.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
• Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
• History of corneal or refractive surgery.
• Biomicroscopy findings greater than Grade 2 at baseline.
• A pathologically dry eye that precludes contact lens wear.
• Monocular (only one eye with functional vision).
• Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
• History of intolerance or hypersensitivity to any component of the investigational products.
• Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
• Other protocol-defined exclusion criteria may apply.