AmetropiaNCT06408649
Post-market Clinical Follow-up Study of Alcon TOTAL30® Contact Lenses (Lehfilcon A)
An observational study of Ametropia and Myopia, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices. Read more about this study
- Who is it for?
- Ages 7 years and older
- What is being tested?
- Lehfilcon A spherical contact lenses and Lehfilcon A toric contact lenses
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 22 Apr 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
- Child, Adult, Older adult
Study population: Subjects will be recruited from clinical sites located in the United States.
Who may be able to join
- Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint;
- Best corrected spectacle visual acuity (VA) 20/25 or better at baseline;
- Healthy, non-diseased eyes;
- Other protocol-specified inclusion criteria may apply.
- Key Exclusion Criteria, as determined or known by the Investigator:
- Any ocular disease or condition that would contraindicate contact lens wear present at baseline;
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- The use of systemic or ocular medications that would contraindicate contact lens wear at baseline;
- Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation;
- Other protocol-specified exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Post-market Clinical Follow-up Study of Alcon TOTAL30® Spherical Contact Lenses (Lehfilcon A) and TOTAL30® for Astigmatism Contact Lenses (Lehfilcon A)
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.
Read the detailed description
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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review).
The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism
- Being tested
- Lehfilcon A spherical contact lenses, Lehfilcon A toric contact lenses
- Keywords
- Contact lenses
- 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.
Lehfilcon A spherical contact lensesDevice
Also called TOTAL30® Spherical Contact Lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)
Lehfilcon A toric contact lensesDevice
Also called TOTAL30® for Astigmatism Contact Lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism
| Study group | Role | What they receive |
|---|---|---|
| TOTAL30 Sphere | Lehfilcon A spherical contact lenses worn in both eyes in a real-world setting Receives: Device: Lehfilcon A spherical contact lenses | |
| TOTAL30 for Astigmatism | Lehfilcon A toric contact lenses worn in both eyes in a real-world setting Receives: Device: Lehfilcon A toric 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 1-year 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
Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Measured: Up to Year 1
Incidence of microbial keratitis
Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
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 posted10 May 2024
- Study start15 Nov 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 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 AmetropiaStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408649
- Sponsor's protocol ID
- CLY935-N001
- Status last verified
- Jul 2025
- First submitted
- 7 May 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 TOTAL30® Spherical Contact Lenses (Lehfilcon A) and TOTAL30® for Astigmatism Contact Lenses (Lehfilcon A)
- ClinicalTrials.gov ID
- NCT06408649
- Acronym / sponsor ID
- CLY935-N001
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism
- Keywords
- Contact lenses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 10 May 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 Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.
Detailed description
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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review).
The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOTAL30 Sphere | – | Device: Lehfilcon A spherical contact lensesLehfilcon A spherical contact lenses worn in both eyes in a real-world setting |
| TOTAL30 for Astigmatism | – | Device: Lehfilcon A toric contact lensesLehfilcon A toric contact lenses worn in both eyes in a real-world setting |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from clinical sites located in the United States.
Key inclusion criteria (9 listed)
- Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint;
- Best corrected spectacle visual acuity (VA) 20/25 or better at baseline;
- Healthy, non-diseased eyes;
- Other protocol-specified inclusion criteria may apply.
- Any ocular disease or condition that would contraindicate contact lens wear present at baseline;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lehfilcon A spherical contact lensesAlso: TOTAL30® Spherical Contact LensesSilicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) | Device | TOTAL30 Sphere |
| Lehfilcon A toric contact lensesAlso: TOTAL30® for Astigmatism Contact LensesSilicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism | Device | TOTAL30 for Astigmatism |
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 1-year 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
Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Incidence of microbial keratitis
Time frame: Up to Year 1
Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
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
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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, Vision Care study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ametropia and Myopia, run by Alcon Research at 1 site 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 9 inclusion and 0 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 1 site 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.