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

Alcon Research140 enrolled

Overview

The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

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 examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Refractive Errors

Interventions

Verofilcon A spherical soft contact lensesDEVICE

Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)

Verofilcon A toric soft contact lensesDEVICE

Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

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.

Locations (12)

Scripps Optometric Group

San Diego, California, United States

Pearle Vision

Jacksonville, Florida, United States

Vision Health Institute

Orlando, Florida, United States

Outcomes

Primary Outcomes

Distance Visual Acuity with Study Lenses at Baseline

Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.

Time frame: Baseline

Distance Visual Acuity with Study Lenses at Year 1 Follow-Up

Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.

Time frame: Year 1

Incidence of Corneal Infiltrative Events

A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.

Time frame: Up to Year 1

Incidence of Microbial Keratitis

Microbial keratitis is a sight-threatening infection of the cornea.

Time frame: Up to Year 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.