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 |
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.
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.
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