Refractive ErrorsNCT06462456
Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
An observational study of Refractive Errors, run by Alcon Research at 12 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Verofilcon A spherical soft contact lenses and Verofilcon A toric soft contact lenses
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Aug 2024to 11 Mar 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from clinical sites located in the United States.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CORL, Indiana University
Bloomington, Indiana, 47405
Vision Salon Eye Care Associates
Blue Island, Illinois, 60406
Illinois College of Optometry
Chicago, Illinois, 60616
The Eye Doctors Inc
Eden Prairie, Minnesota, 55344
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Pearle Vision
Jacksonville, Florida, 32246
Spectrum Eyecare
Jamestown, New York, 14701
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Vision Health Institute
Orlando, Florida, 32803
Eyecare Professionals, Inc
Powell, Ohio, 43065
Scripps Optometric Group
San Diego, California, 92131
About this study
Official title: 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.
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.
- Conditions
- Refractive Errors
- Being tested
- Verofilcon A spherical soft contact lenses, Verofilcon A toric soft contact lenses
- Keywords
- Myopia, Hyperopia, Astigmatism
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verofilcon A spherical soft contact lensesDevice
Also called PRECISION1™
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
Also called PRECISION1™ for Astigmatism
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
| Study group | Role | What they receive |
|---|---|---|
| PRECISION1 Sphere | Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting Receives: Device: Verofilcon A spherical soft contact lenses | |
| PRECISION1 Toric | Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting Receives: Device: Verofilcon A toric soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity with Study Lenses at Baseline
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Measured: 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.
Measured: Year 1
Incidence of Corneal Infiltrative Events
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Measured: Up to Year 1
Incidence of Microbial Keratitis
Microbial keratitis is a sight-threatening infection of the cornea.
Measured: Up to Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start30 Aug 2024
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, VC, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462456
- Sponsor's protocol ID
- CLE383-I001
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No