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
- Are there results?
- None posted in the registry
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06462456
- Acronym / sponsor ID
- CLE383-I001
- Conditions
- Refractive Errors
- Keywords
- Myopia, Hyperopia, Astigmatism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRECISION1 Sphere | – | Device: Verofilcon A spherical soft contact lensesVerofilcon A spherical soft contact lenses worn in both eyes in a real-world setting |
| PRECISION1 Toric | – | Device: Verofilcon A toric soft contact lensesVerofilcon A toric soft contact lenses worn in both eyes in a real-world setting |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from clinical sites located in the United States.
Key inclusion criteria (5 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verofilcon A spherical soft contact lensesAlso: 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) | Device | PRECISION1 Sphere |
| Verofilcon A toric soft contact lensesAlso: PRECISION1™ for AstigmatismSilicone 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 | Device | PRECISION1 Toric |
Primary outcome
Distance Visual Acuity with Study Lenses at Baseline
Time frame: Baseline
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Distance Visual Acuity with Study Lenses at Year 1 Follow-Up
Time frame: Year 1
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Incidence of Corneal Infiltrative Events
Time frame: Up to Year 1
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Incidence of Microbial Keratitis
Time frame: Up to Year 1
Microbial keratitis is a sight-threatening infection of the cornea.
Results and safety
The study was stopped early (reason given: Management decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Refractive Errors
Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Refractive Errors
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Refractive Errors
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial
Myopia, Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, VC study director
Alcon Research, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Alcon Research at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Management decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Visual Acuity with Study Lenses at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.