Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Inclusion Criteria:

• existing contact lens wearer
• read and signed statement of informed consent
• has clear central cornea
• requires spherical distance correction

Exclusion Criteria:

• has worn RGP contact lenses within the last 30 days
• is using any ocular medication
• has had refractive surgery
• has an infectious disease
• is pregnant or lactating
• is participating in another clinical research study