Evaluation of the Feasibility 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

NCT01309906

688E

Details and patient eligibility

About

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

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 in each eye.
• Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

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

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Investigational lens

Experimental group

Description:

Bausch \& Lomb investigational silicone hydrogel lens

Treatment:

Device: Investigational lens

Air Optix Aqua lens

Active Comparator group

Description:

Ciba Vision Air Optix Aqua contact lens

Treatment:

Device: Air Optix Aqua lens