Evaluation of a New Daily Disposable Multifocal Contact Lens Design
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2013 |
| Start Date: | October 2013 |
| End Date: | November 2013 |
| Contact: | Alcon Call Center |
| Email: | alcon.medinfo@alcon.com |
| Phone: | 1-888-451-3937 |
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.
- Be 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 subjects (only one eye with functional vision).
- History of intolerance or hypersensitivity to any component of the test articles.
- Other protocol-defined exclusion criteria may apply.
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