Astigmatism, Myopia
Conditions
Keywords
daily disposable, kalifilcon A, samfilcon A, astigmatism, contact lens, toric, Ultra
Brief 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 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.
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.
Interventions
DEVICEkalifilcon A daily disposable toric contact lenses
kalifilcon A daily disposable toric contact lens (LD213001) - hydrophilic siloxane copolymer, 55% water, UV-absorbing, blue visibility tint; multiple powers.
DEVICEUltra for Astigmatism (samfilcon A) contact lenses
Device: Ultra for Astigmatism (samfilcon A) contact lens - commercially available, parameter-matched powers.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2-way, 2-period crossover; each participant wore both lens types (Test and Comparator) in a randomized order, \ 1 week each.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. Have no active ocular disease or allergic conjunctivitis. 4. Not be using any topical ocular medications. 5. Be willing and able to follow instructions. 6. Have signed a statement of informed consent.
Exclusion criteria
1. Participating in a conflicting study. 2. Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (logMAR) | One week (follow-up visit) | Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m). |
Countries
United States
Contacts
STUDY_DIRECTORJeffery Schafer
Bausch & Lomb Incorporated
Participant flow
Recruitment details
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.
Pre-assignment details
Experienced soft contact lens wearers requiring astigmatic correction were screened for eligibility. Eligible participants were randomized to the order (crossover design) in which they wore the two study lens types and were dispensed study lenses.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 37.2 Years STANDARD_DEVIATION 10.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 35 |
| other Total, other adverse events | 1 / 32 | 0 / 35 |
| serious Total, serious adverse events | 0 / 32 | 0 / 35 |
Outcome results
None listed