Myopia and Hyperopia and Presbyopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis
Interventions
DEVICEnew silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent * Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study * Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye * Subjects must have clear central corneas and be free of any anterior segment disorders * Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week * Subjects must habitually wear a multifocal lens in each eye * Subjects must be an adapted multifocal soft contact lens wearer for a minimum of 6 months * Subjects must require distance lens correction from +3.00 to -6.00 D in each eye * Subjects must be presbyopic and require near add correction from +0.75 to +2.50 D in each eye * Subjects must have access to an internet connection to complete an online survey and be able to receive text message
Exclusion criteria
* Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation * Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: * She is currently pregnant * She plans to become pregnant during the study * She is breastfeeding * Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study * Subjects with an active ocular disease * Subjects who have had any corneal surgery (e.g., refractive surgery) * Subjects who have worn gas-permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months * Subjects who currently wear monovision or toric contact lenses * Subjects who are not correctable to 32 letters (0.3 logMAR) with bilateral soft multifocal contact lenses * Subjects with an ocular astigmatism \>1.00 D in either eye * Subjects with anisometropia (spherical equivalent) \>2.00 D * Subjects with any Grade ≥2 finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible * Any Present finding during the slit lamp examination that, in the Investigator's opinion, interferes with contact lens wear * Any scar or neovascularization within the central 6 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible for this study * Subjects who are amblyopic * Subjects using any systemic or topical ocular medication that will, in the Investigator's opinion, affect ocular physiology or lens performance * Subjects who are allergic to any component in the study care products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Agreeing With the Statement Clear Vision: Near, Far, and In-between | 3 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens New silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | 294 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued | 9 |
Baseline characteristics
| Characteristic | Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 6.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 252 Participants |
| Region of Enrollment United States | 294 participants |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 294 |
| other Total, other adverse events | 0 / 294 |
| serious Total, serious adverse events | 0 / 294 |
Outcome results
Primary
Proportion of Subjects Agreeing With the Statement Clear Vision: Near, Far, and In-between
Time frame: 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens | Proportion of Subjects Agreeing With the Statement Clear Vision: Near, Far, and In-between | 241 Participants |