PresbyopiaNCT06469242
Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
A study testing Serafilcon A multifocal contact lenses, Senofilcon A multifocal contact lenses and CLEAR CARE® Cleaning & Disinfecting Solution in people with Presbyopia, run by Alcon Research at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Serafilcon A multifocal contact lenses, Senofilcon A multifocal 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
- 106 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Jul 2024to 8 Oct 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
- Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Currently pregnant or lactating.
- History of amblyopia, strabismus, or binocular vision abnormalities.
- Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
- Monovision contact lens wearers and wearers of contact lens in one eye only.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Kurata Eyecare Center
Los Angeles, California, 90013
Drs. Giedd, P.A.
Maitland, Florida, 32751
Wesley Optometric Consulting
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Elsa Pao, OD
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Insight Research Clinic LLC
Powell, Ohio, 43065
About this study
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
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 14 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 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.
- Conditions
- Presbyopia
- Being tested
- Serafilcon A multifocal contact lenses, Senofilcon A multifocal contact lenses, CLEAR CARE® Cleaning & Disinfecting Solution
- Keywords
- Multifocal, Myopia, Hyperopia
- Medical subject headings
- Presbyopia, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serafilcon A multifocal contact lensesDevice
Also called LID233309
Investigational multifocal soft contact lenses
Senofilcon A multifocal contact lensesDevice
Also called ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN, Oasys MF
Commercially available multifocal soft contact lenses
CLEAR CARE® Cleaning & Disinfecting SolutionDevice
Also called CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfection system
| Study group | Role | What they receive |
|---|---|---|
| LID233309, then Oasys MF | Other | Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Serafilcon A multifocal contact lenses; Device: Senofilcon A multifocal contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution |
| Oasys MF, then LID233309 | Other | Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Serafilcon A multifocal contact lenses; Device: Senofilcon A multifocal 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 Week 1
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). No hypothesis testing was pre-specified for this endpoint.
Measured: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 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 posted21 Jun 2024
- Study start18 Jul 2024
- Primary completion8 Oct 2024
- Study completion8 Oct 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
- 106 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
- NCT06469242
- Sponsor's protocol ID
- CLM234-C001
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 9 Oct 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 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT06469242
- Acronym / sponsor ID
- CLM234-C001
- Conditions
- Presbyopia
- Keywords
- Multifocal, Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Posted 9 Oct 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 the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
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 14 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 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID233309, then Oasys MF | Other | Device: Serafilcon A multifocal contact lenses, Device: Senofilcon A multifocal contact lenses, Device: CLEAR CARE® Cleaning & Disinfecting SolutionSerafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. |
| Oasys MF, then LID233309 | Other | Device: Serafilcon A multifocal contact lenses, Device: Senofilcon A multifocal contact lenses, Device: CLEAR CARE® Cleaning & Disinfecting SolutionSenofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Currently pregnant or lactating.
- History of amblyopia, strabismus, or binocular vision abnormalities.
- Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
- 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 |
|---|---|---|
| Serafilcon A multifocal contact lensesAlso: LID233309Investigational multifocal soft contact lenses | Device | LID233309, then Oasys MF, Oasys MF, then LID233309 |
| Senofilcon A multifocal contact lensesAlso: ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN, Oasys MFCommercially available multifocal soft contact lenses | Device | LID233309, then Oasys MF, Oasys MF, then LID233309 |
| CLEAR CARE® Cleaning & Disinfecting SolutionAlso: CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfection system | Device | LID233309, then Oasys MF, Oasys MF, then LID233309 |
Primary outcome
Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1
Time frame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) 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). No hypothesis testing was pre-specified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serafilcon A multifocal contact lenses, Senofilcon A multifocal contact lenses and CLEAR CARE® Cleaning & Disinfecting Solution in people with Presbyopia, run by Alcon Research at 8 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 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 9 Oct 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 Week 1 (time frame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 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 9 Oct 2025.