An interventional study of kalifilcon A daily disposable toric contact lenses and Ultra for Astigmatism (samfilcon A) contact lenses in Myopia and Astigmatism, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants wore kalifilcon A daily disposable toric (LD213001) lenses bilaterally as a daily disposable lens for \~1 week.
Device: kalifilcon A daily disposable toric contact lenses
Participants wore commercially available Ultra for Astigmatism (samfilcon A) lenses bilaterally in parameter-matched powers for \~1 week.
Device: Ultra for Astigmatism (samfilcon A) contact lenses
kalifilcon A daily disposable toric contact lens (LD213001) - hydrophilic siloxane copolymer, 55% water, UV-absorbing, blue visibility tint; multiple powers.
Device: Ultra for Astigmatism (samfilcon A) contact lens - commercially available, parameter-matched powers.
Also known as: Ultra for Astigmatism
Visual Acuity (logMAR)
Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m).
Time frame: One week (follow-up visit)
Participants were recruited and enrolled at a single investigational site (Bausch + Lomb Research Clinic, Rochester, NY, United States). Enrollment occurred 14-16 February 2022; the last participant exited 10 May 2022.
| Milestone | Kalifilcon A Daily Disposable Toric First, Then Ultra for Astigmatism | Ultra for Astigmatism First, Then Kalifilcon A Daily Disposable Toric |
|---|---|---|
| Started | 17 | 18 |
| Completed | 17 | 15 |
| Not completed | 0 | 3 |
| Withdrew: Appropriate contact lens power was not available | 0 | 3 |
| Milestone | Kalifilcon A Daily Disposable Toric First, Then Ultra for Astigmatism | Ultra for Astigmatism First, Then Kalifilcon A Daily Disposable Toric |
|---|---|---|
| Started | 17 | 15 |
| Completed | 15 | 13 |
| Not completed | 2 | 2 |
| Withdrew: Unavailable/missed visits | 2 | 2 |
Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m).
| LogMAR Visual acuity after 1 week | Kalifilcon A Daily Disposable Toric (LD213001) (Test) | Ultra for Astigmatism (Samfilcon A) (Comparator) |
|---|---|---|
| Visual Acuity (logMAR) | -0.138 ± 0.0844 | -0.126 ± 0.0770 |
Collected over Approximately 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kalifilcon A Daily Disposable Toric (LD213001) (Test) | 0/32 (0%) | 0/32 (0%) | 1/32 (3.1%) |
| Ultra for Astigmatism (Samfilcon A) (Comparator) | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Event | Kalifilcon A Daily Disposable Toric (LD213001) (Test) | Ultra for Astigmatism (Samfilcon A) (Comparator) |
|---|---|---|
| significant, non-serious (peripheral corneal ulcer)Eye disorders | 1/32 | 0/35 |
Seven enrolled participants were discontinued and were not included in the data. 35 were enrolled and 28 completed the study and were included in the data
| Age, Categorical(Participants) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 0 |
| Age, Continuous(Years) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| Mean | 37.2 ± 10.45 |
| Sex: Female, Male(Participants) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| Female | 9 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | Total - All Participants, Combined Across Treatment Sequences |
|---|---|
| United States | 28 |
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Bausch & Lomb Incorporated