A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

Bausch & Lomb Incorporated20 sites in 1 country301 target enrollmentNovember 7, 2022

ConditionsMyopia and Hyperopia and Presbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia and Hyperopia and Presbyopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 301
Locations: 20
Primary Endpoint: Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 7, 2022

End Date

January 16, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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