Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens (NCT05660577) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
United States301 participantsStarted 2022-11-07
Plain-language 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
Who can participate
Age range40 Years
SexALL
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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 participat…
What they're measuring
1
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between