Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | Device | new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between | 3 weeks |
Not provided
Not provided
Inclusion Criteria:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric White OD Inc | San Diego | California | 92123 | United States | ||
| Lee & Woo Optometry |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | e 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2022 | Mar 11, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| San Francisco |
| California |
| 94112 |
| United States |
| Chester T Roe III MD Prof LLC | Denver | Colorado | 80246 | United States |
| Pearle Vision | Jacksonville | Florida | 32246 | United States |
| Eola Eyes | Orlando | Florida | 32803 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Golden Vision | Sarasota | Florida | 34237 | United States |
| The Eyecare Studio, LLC | Decatur | Georgia | 30035 | United States |
| Family Eyecare Center | Leavenworth | Kansas | 66048 | United States |
| Kannarr EyeCare | Pittsburg | Kansas | 66762 | United States |
| Casco Bay EyeCare | Portland | Maine | 04101 | United States |
| Cornea and Contact Lens Institute of Minnesota | Edina | Minnesota | 55436 | United States |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| Spectrum Eyecare | Jamestown | New York | 14701 | United States |
| Saccco Eye Group | Vestal | New York | 13850 | United States |
| Oculus Research | Raleigh | North Carolina | 27603 | United States |
| CORE, Inc. | Shelby | North Carolina | 28150 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Optometric Physicians of Middle Tennessee | Nashville | Tennessee | 37205 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
3-Week
Ocular Adverse Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 294 | 0 | 294 | 0 | 294 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch & Lomb | 5102595284 | aloncaric@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2023 | Mar 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|