PresbyopiaNCT05325931
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia
A study testing kalifilcon A Daily Disposable Multifocal and samfilcon A for Presbyopia in people with Presbyopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- kalifilcon A Daily Disposable Multifocal and samfilcon A for Presbyopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2022to 28 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
- Have signed a statement of informed consent.
Who cannot join
- Participating in a conflicting study.
- Considered by the Investigator to not be a suitable candidate for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.
- Conditions
- Presbyopia
- Being tested
- kalifilcon A Daily Disposable Multifocal, samfilcon A for Presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kalifilcon A Daily Disposable MultifocalDevice
kalifilcon A Daily Disposable Multifocal contact lenses (Low Add [LD191001] and High Add [LD191002] designs), worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week.
samfilcon A for PresbyopiaDevice
Ultra for Presbyopia (samfilcon A) Low and High Add contact lenses, worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week.
| Study group | Role | What they receive |
|---|---|---|
| kalifilcon A First, Then samfilcon A for Presbyopia | Experimental | Participants wore kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable, for approximately 1 week. Receives: Device: kalifilcon A Daily Disposable Multifocal; Device: samfilcon A for Presbyopia |
| samfilcon A for Presbyopia First, Then kalifilcon A | Experimental | Participants wore Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable, for approximately 1 week. Receives: Device: kalifilcon A Daily Disposable Multifocal; Device: samfilcon A for Presbyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (Distance)
Mean Binocular logMAR Visual Acuity at Distance (6m)
Measured: One week (follow-up visit)
Visual Acuity (Near)
Mean Binocular logMAR Visual Acuity at Near (40cm)
Measured: One week (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start25 Feb 2022
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
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.
- 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
- Model description
- Participants wore each type of contact lens in a random order for approximately 1 week.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Schafer, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325931
- Sponsor's protocol ID
- ROC2-22-005
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2022
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
- ClinicalTrials.gov ID
- NCT05325931
- Acronym / sponsor ID
- ROC2-22-005
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants wore each type of contact lens in a random order for approximately 1 week.
| Arm | Type | Receives |
|---|---|---|
| kalifilcon A First, Then samfilcon A for Presbyopia | Experimental | Device: kalifilcon A Daily Disposable Multifocal, Device: samfilcon A for PresbyopiaParticipants wore kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable, for approximately 1 week. |
| samfilcon A for Presbyopia First, Then kalifilcon A | Experimental | Device: kalifilcon A Daily Disposable Multifocal, Device: samfilcon A for PresbyopiaParticipants wore Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable, for approximately 1 week. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
Key exclusion criteria (2 listed)
- Participating in a conflicting study.
- Considered by the Investigator to not be a suitable candidate for participation.
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 |
|---|---|---|
| kalifilcon A Daily Disposable Multifocalkalifilcon A Daily Disposable Multifocal contact lenses (Low Add [LD191001] and High Add [LD191002] designs), worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week. | Device | kalifilcon A First, Then samfilcon A for Presbyopia, samfilcon A for Presbyopia First, Then kalifilcon A |
| samfilcon A for PresbyopiaUltra for Presbyopia (samfilcon A) Low and High Add contact lenses, worn bilaterally on a daily-disposable, single-use basis (≥8 hours/day) for approximately 1 week. | Device | kalifilcon A First, Then samfilcon A for Presbyopia, samfilcon A for Presbyopia First, Then kalifilcon A |
Primary outcome
Visual Acuity (Distance)
Time frame: One week (follow-up visit)
Mean Binocular logMAR Visual Acuity at Distance (6m)
Visual Acuity (Near)
Time frame: One week (follow-up)
Mean Binocular logMAR Visual Acuity at Near (40cm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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.
Jeffery Schafer study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kalifilcon A Daily Disposable Multifocal and samfilcon A for Presbyopia in people with Presbyopia, run by Bausch & Lomb Incorporated 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 6 inclusion and 2 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 6 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2026). 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?
Visual Acuity (Distance) (time frame: One week (follow-up visit)). The study lists 2 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 6 Aug 2026.