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 |
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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