Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

The purpose of this clinical study is to assess 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 with frequent replacement.

Subjects will 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 months.

Key Inclusion Criteria:

• Understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
• Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
• Best spectacle corrected visual acuity 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.
• Monovision contact lens wear.
• Any habitual wear of Biofinity lenses.
• Other protocol-defined exclusion criteria may apply.