A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Presbyopia

Treatments: Device: PureVision multifocal contact lens; Device: LD118033 contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539694

744E

Details and patient eligibility

About

The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have physiologically normal anterior segments.
• Be adapted wearers of soft contact lenses and wear a lens in each eye.
• Be presbyopic and require near add correction in each eye.
• Have no active ocular disease or allergic conjunctivitis.
• Must not be using any topical ocular medications.

Exclusion criteria

• Any Grade 2 or greater finding during the slit lamp examination.
• Any scar or neovascularization within the central 4mm of the cornea.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Allergic to any component in the study products.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• An active ocular disease, any corneal infiltrative response or are using any ocular medications.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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126 participants in 2 patient groups

LD118033 contact lens

Experimental group

Description:

Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.

Treatment:

Device: LD118033 contact lens

PureVision multifocal contact lens

Active Comparator group

Description:

PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.

Treatment:

Device: PureVision multifocal contact lens