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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:February 2013
End Date:April 2013
Contact:Alcon Call Center
Phone:1-888-451-3937

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The purpose of this study is to compare the performance of the new DAILIES® AquaComfort
Plus® Multifocal contact lens to the commercially available Focus® DAILIES® Progressives
contact lens.


Inclusion Criteria:

- Sign Informed Consent Document.

- Presbyopic and requires a spectacle add of up to and including 3.00 diopter (D).

- Currently wears soft contact lenses.

- Willing and able to wear multifocal contact lenses in both eyes within the available
range of powers for this trial and to 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).

- Wears 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.
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