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

Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical Soft Contact Lenses (Verofilcon A) and PRECISION1T™ for Astigmatism Contact Lenses (Verofilcon A)

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.

Study Overview

• Status: Terminated
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Verofilcon A spherical soft contact lenses; Device: Verofilcon A toric soft contact lenses

Detailed Description

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 (Actual): 140

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • Scripps Optometric Group
  • Florida
    • Jacksonville, Florida, United States, 32246
      • Pearle Vision
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Illinois
    • Blue Island, Illinois, United States, 60406
      • Vision Salon Eye Care Associates
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • CORL, Indiana University
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • The Eye Doctors Inc
    • Edina, Minnesota, United States, 55436
      • Cornea and Contact Lens Institute of Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • New York
    • Jamestown, New York, United States, 14701
      • Spectrum Eyecare
  • Ohio
    • Powell, Ohio, United States, 43065
      • Eyecare Professionals, Inc
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRECISION1 Sphere; Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting	Device: Verofilcon A spherical soft contact lenses; 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); Other Names: PRECISION1™
PRECISION1 Toric; Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting	Device: Verofilcon A toric soft contact lenses; 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; Other Names: PRECISION1™ for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, VC, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hyperopia; Astigmatism; Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Astigmatism; Refractive Errors
• Other Study ID Numbers: CLE383-I001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No