AmetropiaNCT06165627
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
A study testing Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE in people with Ametropia and Astigmatism, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ametropia, Astigmatism
- What is being tested?
- Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jan 2024to 12 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
- Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
- Willing and able to wear the study lenses as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
- Monovision and multifocal contact lens wearers;
- Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
- Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ProCare Vision Center
Granville, Ohio, 43023
Kurata Eye Care Center
Los Angeles, California, 90012
Elsa Pao, OD
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Pacific Rims Optometry
San Francisco, California, 94127
About this study
The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Read the detailed description
Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.
- Conditions
- Ametropia, Astigmatism
- Being tested
- Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses, CLEAR CARE
- Keywords
- Contact lenses, Myopia
- Medical subject headings
- Refractive Errors, Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lehfilcon A toric contact lensesDevice
Also called TOTAL30™ for Astigmatism, T30fA
Commercially available soft contact lenses worn as indicated
Comfilcon A toric contact lensesDevice
Also called Biofinity® Toric, Biofinity Toric
Commercially available soft contact lenses) worn as indicated
CLEAR CAREDevice
Also called CLEAR CARE® Cleaning & Disinfecting Solution
Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated
| Study group | Role | What they receive |
|---|---|---|
| T30fA, then Biofinity Toric | Other | Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution. Receives: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE |
| Biofinity Toric, then T30fA | Other | Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution. Receives: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Distance Visual Acuity With Study Lenses at Day 30
Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.
Measured: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start23 Jan 2024
- Primary completion12 May 2024
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 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
- NCT06165627
- Sponsor's protocol ID
- CLV201-P003
- Status last verified
- May 2025
- First submitted
- 4 Dec 2023
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06165627
- Acronym / sponsor ID
- CLV201-P003
- Conditions
- Ametropia, Astigmatism
- Keywords
- Contact lenses, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Posted 29 May 2025
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 the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Detailed description
Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T30fA, then Biofinity Toric | Other | Device: Lehfilcon A toric contact lenses, Device: Comfilcon A toric contact lenses, Device: CLEAR CARELehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution. |
| Biofinity Toric, then T30fA | Other | Device: Lehfilcon A toric contact lenses, Device: Comfilcon A toric contact lenses, Device: CLEAR CAREComfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
- Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
- Willing and able to wear the study lenses as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
- Monovision and multifocal contact lens wearers;
- Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
- Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Other protocol-specified 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 |
|---|---|---|
| Lehfilcon A toric contact lensesAlso: TOTAL30™ for Astigmatism, T30fACommercially available soft contact lenses worn as indicated | Device | Biofinity Toric, then T30fA, T30fA, then Biofinity Toric |
| Comfilcon A toric contact lensesAlso: Biofinity® Toric, Biofinity ToricCommercially available soft contact lenses) worn as indicated | Device | Biofinity Toric, then T30fA, T30fA, then Biofinity Toric |
| CLEAR CAREAlso: CLEAR CARE® Cleaning & Disinfecting SolutionCommercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated | Device | Biofinity Toric, then T30fA, T30fA, then Biofinity Toric |
Primary outcome
Mean Distance Visual Acuity With Study Lenses at Day 30
Time frame: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.
Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE in people with Ametropia and Astigmatism, run by Alcon Research at 5 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Distance Visual Acuity With Study Lenses at Day 30 (time frame: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.). 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 29 May 2025.