Clinical trial NCT05660577: Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia and Hyperopia and Presbyopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 301
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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
* 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

Primary outcomes:
measure: Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric White OD Inc
state: California
city: San Francisco
country: United States
facility: Lee & Woo Optometry
state: California
city: Denver
country: United States
facility: Chester T Roe III MD Prof LLC
state: Colorado
city: Jacksonville
country: United States
facility: Pearle Vision
state: Florida
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Decatur
country: United States
facility: The Eyecare Studio, LLC
state: Georgia
city: Leavenworth
country: United States
facility: Family Eyecare Center
state: Kansas
city: Pittsburg
country: United States
facility: Kannarr EyeCare
state: Kansas
city: Portland
country: United States
facility: Casco Bay EyeCare
state: Maine
city: Edina
country: United States
facility: Cornea and Contact Lens Institute of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Koetting Associates
state: Missouri
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Vestal
country: United States
facility: Saccco Eye Group
state: New York
city: Raleigh
country: United States
facility: Oculus Research
state: North Carolina
city: Shelby
country: United States
facility: CORE, Inc.
state: North Carolina
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Optometric Physicians of Middle Tennessee
state: Tennessee
Study officials:
References: