Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
• Other protocol-defined exclusion criteria may apply.