Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
NCT ID: NCT05660577
Last Updated: 2024-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
301 participants
INTERVENTIONAL
2022-11-07
2023-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Locations
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Eric White OD Inc
San Diego, California, United States
Lee & Woo Optometry
San Francisco, California, United States
Chester T Roe III MD Prof LLC
Denver, Colorado, United States
Pearle Vision
Jacksonville, Florida, United States
Eola Eyes
Orlando, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Golden Vision
Sarasota, Florida, United States
The Eyecare Studio, LLC
Decatur, Georgia, United States
Family Eyecare Center
Leavenworth, Kansas, United States
Kannarr EyeCare
Pittsburg, Kansas, United States
Casco Bay EyeCare
Portland, Maine, United States
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, United States
Koetting Associates
St Louis, Missouri, United States
Spectrum Eyecare
Jamestown, New York, United States
Saccco Eye Group
Vestal, New York, United States
Oculus Research
Raleigh, North Carolina, United States
CORE, Inc.
Shelby, North Carolina, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Optometric Physicians of Middle Tennessee
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BL916
Identifier Type: -
Identifier Source: org_study_id
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