A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Bausch + Lomb

Status

Completed

Conditions

Presbyopia

Treatments

Device: Investigational contact lens

Device: PureVision contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01518868

743E

Details and patient eligibility

About

The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

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.
Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
Have no active ocular disease or allergic conjunctivitis.
Must not be using any topical ocular medications.
Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion criteria

Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Anisometropia (spherical equivalent) of greater than 2.00 D.
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
Allergic to any component in the study products.
Ocular astigmatism of greater than 1.00 D in either eye.
Have had any corneal surgery (ie, refractive surgery).
Uses AMO Ultra Care as their habitual lens care regimen.
Is a toric contact lens wearer.
Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.