Multifocal High ADD Contact Lens Proof of Concept Trial

Alcon

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lotrafilcon B multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses (new)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117544

C-13-057

Details and patient eligibility

About

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.

Enrollment: 268 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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268 participants in 2 patient groups

New MF, then AOAMF

Other group

Description:

Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.

Treatment:

Device: Lotrafilcon B multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses (new)

AOAMF, then New MF

Other group

Description:

Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.

Treatment:

Device: Lotrafilcon B multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses (new)