PresbyopiaNCT06461455
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
A study testing Lehfilcon A multifocal for astigmatism contact lenses, Samfilcon A multifocal for astigmatism contact lenses and CLEAR CARE® Cleaning & Disinfecting Solution in people with Presbyopia and Astigmatism, run by Alcon Research at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia, Astigmatism
- What is being tested?
- Lehfilcon A multifocal for astigmatism contact lenses, Samfilcon A multifocal for astigmatism contact lenses and CLEAR CARE® Cleaning & Disinfecting Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 11 sitesUnited States
- Study dates
- 26 Jul 2024to 31 Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
- Willing to not use readers while wearing study contact lenses for duration of the study;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Monovision contact lens wearers and wearers of contact lens in one eye only;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Oculus Research, Inc.
Garner, North Carolina, 27529
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Drs. Giedd, P.A.
Maitland, Florida, 32751
Wesley Optometric Consulting
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Dr.Elsa Pao, O.D
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
Insight Research Clinic LLC
Powell, Ohio, 43065
Dawn M. Rakich, OD
San Antonio, Texas, 78213
Pacific Rims Optometry
San Francisco, California, 94127
About this study
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Read the detailed description
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.
- Conditions
- Presbyopia, Astigmatism
- Being tested
- Lehfilcon A multifocal for astigmatism contact lenses, Samfilcon A multifocal for astigmatism contact lenses, CLEAR CARE® Cleaning & Disinfecting Solution
- Keywords
- Myopia, Hyperopia, Multifocal, Toric
- Medical subject headings
- Presbyopia, Astigmatism, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lehfilcon A multifocal for astigmatism contact lensesDevice
Investigational multifocal contact lenses for astigmatism
Samfilcon A multifocal for astigmatism contact lensesDevice
Also called ULTRA® Multifocal for Astigmatism
Commercially available multifocal contact lenses for astigmatism
CLEAR CARE® Cleaning & Disinfecting SolutionDevice
Also called CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfection system
Lehfilcon A multifocal for astigmatism contact lensesDevice
Investigational multifocal contact lenses for astigmatism
CLEAR CARE® Cleaning & Disinfecting SolutionDevice
Also called CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfection system
| Study group | Role | What they receive |
|---|---|---|
| LID230451, then ULTRA MFfA | Other | Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. Receives: Device: Lehfilcon A multifocal for astigmatism contact lenses; Device: Samfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution |
| ULTRA MFfA, then LID230451 | Other | Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. Receives: Device: Samfilcon A multifocal for astigmatism contact lenses; Device: Lehfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
Measured: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) 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 posted17 Jun 2024
- Study start26 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 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 PresbyopiaStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461455
- Sponsor's protocol ID
- CLR624-C001
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2024
- Last updated
- 24 Dec 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT06461455
- Acronym / sponsor ID
- CLR624-C001
- Conditions
- Presbyopia, Astigmatism
- Keywords
- Myopia, Hyperopia, Multifocal, Toric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Posted 24 Dec 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 evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Detailed description
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID230451, then ULTRA MFfA | Other | Device: Lehfilcon A multifocal for astigmatism contact lenses, Device: Samfilcon A multifocal for astigmatism contact lenses, Device: CLEAR CARE® Cleaning & Disinfecting SolutionLehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. |
| ULTRA MFfA, then LID230451 | Other | Device: Samfilcon A multifocal for astigmatism contact lenses, Device: Lehfilcon A multifocal for astigmatism contact lenses, Device: CLEAR CARE® Cleaning & Disinfecting SolutionSamfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
- Willing to not use readers while wearing study contact lenses for duration of the study;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Monovision contact lens wearers and wearers of contact lens in one eye only;
- 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 |
|---|---|---|
| Lehfilcon A multifocal for astigmatism contact lensesInvestigational multifocal contact lenses for astigmatism | Device | LID230451, then ULTRA MFfA |
| Samfilcon A multifocal for astigmatism contact lensesAlso: ULTRA® Multifocal for AstigmatismCommercially available multifocal contact lenses for astigmatism | Device | LID230451, then ULTRA MFfA, ULTRA MFfA, then LID230451 |
| CLEAR CARE® Cleaning & Disinfecting SolutionAlso: CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfection system | Device | LID230451, then ULTRA MFfA |
| Lehfilcon A multifocal for astigmatism contact lensesInvestigational multifocal contact lenses for astigmatism | Device | ULTRA MFfA, then LID230451 |
| CLEAR CARE® Cleaning & Disinfecting SolutionAlso: CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfection system | Device | ULTRA MFfA, then LID230451 |
Primary outcome
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
Time frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 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.
Sr. Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
11 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 multifocal for astigmatism contact lenses, Samfilcon A multifocal for astigmatism contact lenses and CLEAR CARE® Cleaning & Disinfecting Solution in people with Presbyopia and Astigmatism, run by Alcon Research at 11 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 4 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 24 Dec 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 Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses (time frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) 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 24 Dec 2025.