Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Alcon

Status: Completed

Conditions: Refractive Error; Presbyopia; Hyperopia

Treatments: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951573

C-13-011

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• 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 (only 1 eye with functional vision).
• History of intolerance or hypersensitivity to any component of the test articles.
• 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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36 participants in 2 patient groups

Delefilcon A MF, then AOAMF

Other group

Description:

Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

Treatment:

Device: Delefilcon A multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses

AOAMF, then Delefilcon A MF

Other group

Description:

Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

Treatment:

Device: Delefilcon A multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses