MyopiaNCT05320042
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
A study testing kalifilcon A daily disposable toric contact lenses and Ultra for Astigmatism (samfilcon A) contact lenses in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This single-site, randomized, double-masked (participant and investigator), 2-way crossover, repeated-measures dispensing study evaluated the visual performance of kalifilcon A daily disposable toric (LD213001) contact lenses compared with commercially available Ultra for Astigmatism (samfilcon A) contact lenses in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- kalifilcon A daily disposable toric contact lenses and Ultra for Astigmatism (samfilcon A) contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 10 May 2022
- Phase
- Interventional
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 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 Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses
This single-site, randomized, double-masked (participant and investigator), 2-way crossover, repeated-measures dispensing study evaluated the visual performance of kalifilcon A daily disposable toric (LD213001) contact lenses compared with commercially available Ultra for Astigmatism (samfilcon A) contact lenses in experienced soft contact lens wearers requiring astigmatic correction. Each participant wore both lens types as daily disposable lenses for approximately one week each, in a randomized order.
Read the detailed description
Experienced toric soft contact lens wearers were enrolled and attended a Screening/Baseline visit (informed consent, eligibility, sphero-cylindrical baseline refraction). Participants were fit and dispensed either Test (kalifilcon A LD213001) or Comparator (Ultra for Astigmatism, samfilcon A) lenses in both eyes per a randomization schedule and wore them for ~1 week (7 ±3 days), ≥8 hours/day. Measurements (high-contrast logMAR visual acuity, visual quality, comfort, lens fit, and ocular health) were taken at the dispensing (insertion) visit and the 1-week follow-up visit. Participants then crossed over to the other lens type for a second ~1-week period. Continuous data were summarized with descriptive statistics; paired t-tests were used for parametric measures (p<0.05 significant). Non-inferiority margin for mean binocular logMAR VA was 0.06.
- Conditions
- Myopia, Astigmatism
- Being tested
- kalifilcon A daily disposable toric contact lenses, Ultra for Astigmatism (samfilcon A) contact lenses
- Keywords
- daily disposable, kalifilcon A, samfilcon A, astigmatism, contact lens, toric, Ultra
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kalifilcon A daily disposable toric contact lensesDevice
kalifilcon A daily disposable toric contact lens (LD213001) - hydrophilic siloxane copolymer, 55% water, UV-absorbing, blue visibility tint; multiple powers.
Ultra for Astigmatism (samfilcon A) contact lensesDevice
Also called Ultra for Astigmatism
Device: Ultra for Astigmatism (samfilcon A) contact lens - commercially available, parameter-matched powers.
| Study group | Role | What they receive |
|---|---|---|
| kalifilcon A Daily Disposable Toric (LD213001) | Experimental | Participants wore kalifilcon A daily disposable toric (LD213001) lenses bilaterally as a daily disposable lens for ~1 week. Receives: Device: kalifilcon A daily disposable toric contact lenses |
| Ultra for Astigmatism (samfilcon A) | Active comparator | Participants wore commercially available Ultra for Astigmatism (samfilcon A) lenses bilaterally in parameter-matched powers for ~1 week. Receives: Device: Ultra for Astigmatism (samfilcon A) contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (logMAR)
Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m).
Measured: One week (follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start14 Feb 2022
- Primary completion10 May 2022
- Study completion10 May 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 MyopiaStudies 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
- 2-way, 2-period crossover; each participant wore both lens types (Test and Comparator) in a randomized order, \~1 week each.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 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
- NCT05320042
- Sponsor's protocol ID
- ROC2-21-013
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2022
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No