Presbyopia
Conditions
Brief 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. 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.
Interventions
DEVICEkalifilcon A Daily Disposable Multifocal
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.
DEVICEsamfilcon A for Presbyopia
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.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants wore each type of contact lens in a random order for approximately 1 week.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Participating in a conflicting study. * Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (Distance) | One week (follow-up visit) | Mean Binocular logMAR Visual Acuity at Distance (6m) |
| Visual Acuity (Near) | One week (follow-up) | Mean Binocular logMAR Visual Acuity at Near (40cm) |
Countries
United States
Contacts
STUDY_DIRECTORJeffery Schafer
Bausch & Lomb Incorporated
Participant flow
Recruitment details
30 patients were screened for eligibility between February 25, 2022 and March 15, 2022.
Pre-assignment details
30 subjects were enrolled and randomized 1:1 to one of two treatment sequences. (No screen failures.)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.9 Years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed