Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

Bausch + Lomb

Status

Completed

Conditions

Myopia and Hyperopia and Presbyopia

Treatments

Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT05660577

BL916

Details and patient eligibility

About

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

Enrollment

301 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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