Multifocal High ADD Contact Lens Proof of Concept Trial

Launched by ALCON RESEARCH · Apr 16, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.