Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses

Launched by ALCON RESEARCH · Jun 12, 2024

Keywords

ClinConnect Summary

This study consists of a Baseline Visit and a Year 1 Visit.

The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.

The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens exami...

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an Institutional Review Board (IRB), unless appropriate consent waiver for the retrospective chart review is provided by the IRB.
• • Verofilcon A (sphere or toric) contact lens wear as described in the protocol.
• • Best corrected spectacle distance visual acuity (VA) 20/25 or better at baseline.
• • Healthy, non-diseased eyes, as determined/known by the Investigator.
• • Other protocol-defined inclusion criteria may apply.
• Key Exclusion Criteria:
• • Any ocular disease or condition that would contraindicate contact lens wear present at baseline.
• • Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
• • Other protocol-defined exclusion criteria may apply.