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

NCT06462456 | Terminated FDA Device

• 1 other identifier: CLE383-I001
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Refractive Errors

Keywords

Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (4)

• Distance Visual Acuity with Study Lenses at Baseline

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

  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.

  Year 1

• Incidence of Corneal Infiltrative Events

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

  Up to Year 1

• Incidence of Microbial Keratitis

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

  Up to Year 1

Study Arms (2)

PRECISION1 Sphere

Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting

Device: Verofilcon A spherical soft contact lenses

PRECISION1 Toric

Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting

Device: Verofilcon A toric soft contact lenses

Interventions

Verofilcon A spherical soft contact lenses DEVICE

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)

Also known as: PRECISION1™

PRECISION1 Sphere

Verofilcon A toric soft contact lenses DEVICE

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

Also known as: PRECISION1™ for Astigmatism

PRECISION1 Toric

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical sites located in the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (12)

Scripps Optometric Group

San Diego, California, 92131, United States

Location

Pearle Vision

Jacksonville, Florida, 32246, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Vision Salon Eye Care Associates

Blue Island, Illinois, 60406, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

CORL, Indiana University

Bloomington, Indiana, 47405, United States

Location

The Eye Doctors Inc

Eden Prairie, Minnesota, 55344, United States

Location

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Spectrum Eyecare

Jamestown, New York, 14701, United States

Location

Eyecare Professionals, Inc

Powell, Ohio, 43065, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, VC

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: August 30, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)