ClinicalTrials.gg
TerminatedNCT06462456Updated Jul 20, 2025

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

An observational study in Refractive Errors, sponsored by Alcon Research. Terminated at 12 sites in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.

Primary conditionAstigmatismRegistry: Refractive ErrorsReclassifiedWhy we changed it
Registry
Refractive Errors — the first condition term the registry derived for this study.
ClinicalTrials.gg
Astigmatism
Why
  1. The study's title name Astigmatism, a narrower term within Refractive Errors.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Alcon Research (part of Alcon) · Observational

Why this study was terminated
Management decision
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
140
Ages
7 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Refractive Errors

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Keywords

  • Myopia
  • Hyperopia
  • Astigmatism
03

In context

Astigmatism Reclassified

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's enrollment of 140 is above the median of 100 across 82 observational studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Compared within Astigmatism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Refractive Errors. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Key Inclusion Criteria:

  • Subject (or subject's legal representative) is able to understand and sign an /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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceVerofilcon 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)

    Also known as: PRECISION1™

  • DeviceVerofilcon 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

    Also known as: PRECISION1™ for Astigmatism

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Incidence of Microbial Keratitis

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

    Time frame: Up to Year 1

07

Study locations

12 sites
  • Scripps Optometric Group
    San Diego, California 92131, United States
  • Pearle Vision
    Jacksonville, Florida 32246, United States
  • Vision Health Institute
    Orlando, Florida 32803, United States
  • Vision Salon Eye Care Associates
    Blue Island, Illinois 60406, United States
  • Illinois College of Optometry
    Chicago, Illinois 60616, United States
  • CORL, Indiana University
    Bloomington, Indiana 47405, United States
  • The Eye Doctors Inc
    Eden Prairie, Minnesota 55344, United States
  • Cornea and Contact Lens Institute of Minnesota
    Edina, Minnesota 55436, United States
  • Complete Eye Care of Medina
    Medina, Minnesota 55340, United States
  • Spectrum Eyecare
    Jamestown, New York 14701, United States
  • Eyecare Professionals, Inc
    Powell, Ohio 43065, United States
  • Optometry Group, PLLC
    Memphis, Tennessee 38111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06462456
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
Aug 30, 2024
Primary completion
Mar 11, 2025
Completion
Mar 11, 2025
Last update
Jul 20, 2025

Study contacts

Clinical Trial Lead, VC
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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