Product Performance of a New Silicone Hydrogel Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: senofilcon A; Device: kalifilcon A; Device: delefilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04901897

893

Details and patient eligibility

About

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

Enrollment: 805 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
• myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
• correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
• free of any anterior segment disorders.
• adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
• access to internet connection and personal email to send/receive emails.
• habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion criteria

• participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
• have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
• using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
• refractive astigmatism of greater than 0.75 D in either eye.
• anisometropia (spherical equivalent) of greater than 2.00 D.
• amblyopic.
• have had any corneal surgery (e.g., refractive surgery).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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805 participants in 3 patient groups

kalifilcon A

Experimental group

Description:

kalifilcon A daily disposable contact lens

Treatment:

Device: kalifilcon A

delefilcon A

Active Comparator group

Description:

DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses

Treatment:

Device: delefilcon A

senofilcon A

Active Comparator group

Description:

Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Treatment:

Device: senofilcon A