Product Feasibility of a New Silicone Hydrogel Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: Acuvue Oasys Lens; Device: Air Optix Aqua Lens; Device: Investigational Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309100

672E

Details and patient eligibility

About

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require lens correction

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 with an active ocular disease or are using any ocular medication.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

Trial design

144 participants in 3 patient groups

Investigational Lens

Experimental group

Description:

Bausch \& Lomb investigational silicone hydrogel lens.

Treatment:

Device: Investigational Lens

Acuvue Oasys Lens

Active Comparator group

Description:

Johnson \& Johnson Acuvue Oasys contact lens.

Treatment:

Device: Acuvue Oasys Lens

Air Optix Aqua Lens

Active Comparator group

Description:

Ciba Vision Air Optix Aqua contact lens.

Treatment:

Device: Air Optix Aqua Lens