A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses; Device: Bausch & Lomb SofLens daily disposable contact lenses.; Device: Novel Bausch & Lomb daily disposable contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784641

496

Details and patient eligibility

About

Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be myopic and require lens correction in both eyes.

Exclusion criteria

• Subjects with any systemic disease affecting ocular health.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects wearing monovision, multifocal or toric contact lenses.
• Subjects with grade 2 or greater slit lamp findings.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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567 participants in 3 patient groups

Novel Bausch & Lomb Contact Lens

Experimental group

Description:

Novel Bausch \& Lomb daily disposable contact lenses

Treatment:

Device: Novel Bausch & Lomb daily disposable contact lenses

SofLens

Active Comparator group

Description:

Bausch \& Lomb SofLens daily disposable contact lenses

Treatment:

Device: Bausch & Lomb SofLens daily disposable contact lenses.

Acuvue

Active Comparator group

Description:

Johnson and Johnson 1-Day Acuvue Moist contact lenses

Treatment:

Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses