AOSEPT (CLEAR CARE) PLUS Study

AOSEPT™ PLUS With HydraGlyde FID 120947A and AOCup Lens Case (CLEAR CARE PLUS) and AOSEPT™ PLUS FID 119056 and AOCup Lens Case (CLEAR CARE) Family PMCF Study

The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Key Inclusion Criteria:

• Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
• Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
• Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular disease or condition that would contraindicate contact lens wear.
• Use of systemic or ocular medication that would contraindicate contact lens wear.
• Any known sensitivity to any ingredients in the study products.
• Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
• Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
• Other protocol-specified exclusion criteria may apply.