Multifocal High ADD Contact Lens Proof of Concept Trial



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:5/5/2014
Start Date:April 2014
End Date:June 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design

The purpose of this study is to evaluate the visual performance of a new multifocal High ADD
contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD
Contact Lens.


Inclusion Criteria:

- Must sign an Informed Consent document;

- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;

- Current or previous soft contact lens wearer;

- Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum
Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)]
or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact
Lenses;

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

- Manifest cylinder less than or equal to 1.00 D;

- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at
distance (as determined by manifest refraction);

- 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, as determined
by the investigator;

- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated, as determined by the investigator; or any use of topical ocular
medications that would require instillation during contact lens wear;

- Any history of herpetic keratitis;

- History of corneal or refractive surgery, irregular cornea or unilateral
pseudophakia;

- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade
3) or severe (Grade 4);

- Corneal vascularization that is mild (Grade 2) or higher;

- A pathologically dry eye that precludes contact lens wear;

- Monocular (only 1 eye with functional vision);

- Anisometropia ≥ 1.50 D (contact lens distance prescription);

- Clinically significant (> 1 millimeter) anisocoria;

- 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 within the previous 30 days;

- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;

- Any ocular or systemic medical condition that may, in the opinion of the
Investigator, preclude safe administration of the study lenses or affect the results
of this study;

- Other protocol-defined exclusion criteria may apply.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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