Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Bausch + Lomb

Status: Completed

Conditions: Vision Disorders

Treatments: Device: PureVision Multi-Focal contact lenses; Device: SofLens59 contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985231

630

Details and patient eligibility

About

This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Enrollment: 272 patients

Sex: All

Ages: 30 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
• Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion criteria

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
• Subjects with any systemic disease affecting ocular health
• Subjects with an active ocular disease or using any ocular medication.
• Subjects who have had any corneal surgery (eg, refractive surgery).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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272 participants in 2 patient groups

PureVision Multi-Focal contact lenses

Experimental group

Treatment:

Device: PureVision Multi-Focal contact lenses

SofLens59 contact lens

Active Comparator group

Treatment:

Device: SofLens59 contact lens