Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
• Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Habitually wearing Biofinity lenses;
• Monovision or multifocal contact lens wearers;
• Other protocol-defined exclusion criteria may apply.