A Study to Evaluate a New Silicone Hydrogel Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: Air Optix Aqua lens; Device: Investigational Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309893

687E

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 lenses.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion criteria

• 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.
• 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 care products.

Trial design

66 participants in 2 patient groups

Investigational Lens

Experimental group

Description:

Bausch \& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.

Treatment:

Device: Investigational Lens

Device: Air Optix Aqua lens

Air Optix Aqua Lens

Active Comparator group

Description:

Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.

Treatment:

Device: Investigational Lens

Device: Air Optix Aqua lens