A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens

Completed · Not applicable

Conditions studied: Contact Lens Wear

In brief

This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Key facts

Study ID

NCT04158466

Run by

Bausch & Lomb Incorporated

People needed

252

Starts

2019-05-31

Expected to finish

2019-11-12

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
• Participants must be myopic and require lens correction from -0.25 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
• Participants must be correctable through spherocylindrical refraction and with soft spherical contact lenses to 40 letters (0.14 logMAR) or better (2 meters distance, high-contrast chart) in each eye.
• Participants must be free of any anterior segment disorders.
• Participants must be adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis for approximately 3 months.
• Participants 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 other contact lenses or solutions other than those provided for the duration of the study.

You may not qualify if…

• Participation 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.
• Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they are currently pregnant, plans to become pregnant during the study, or is breastfeeding
• Participants 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.
• Participants with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants with an active ocular disease or who are using any ocular medication.
• Participants who currently wear monovision, multifocal, or toric contact lenses.
• Participants with an ocular astigmatism of greater than 1.00 D in either eye.
• Participants with anisometropia (spherical equivalent) of greater than 2.00 D.
• Participants with any Grade 2 or greater finding during the slit lamp examination. Participants with corneal infiltrates of any grade.
• Participants with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea.
• Participants who are aphakic.
• Participants who are amblyopic.
• Participants who have had any corneal surgery (for example, refractive surgery).
• Participants who are allergic to any component in the study care products.
• The participant is an employee of the investigative site.
• The participant, or a member of the participant's household, is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician.
• The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Johnson \& Johnson).
• The participant, or a member of the participant's household, is an employee of a market research firm.

Where it is running

• Bausch Site 8 — Los Angeles, California, United States
• Bausch Site 9 — San Francisco, California, United States
• Bausch Site 10 — Torrance, California, United States
• Bausch Site 12 — Torrance, California, United States
• Bausch Site 6 — Sarasota, Florida, United States
• Bausch Site 16 — Honolulu, Hawaii, United States
• Bausch Site 4 — ‘Aiea, Hawaii, United States
• Bausch Site 7 — Pittsburg, Kansas, United States
• Bausch Site 11 — Bloomington, Minnesota, United States
• Bausch Site 1 — St Louis, Missouri, United States
• Bausch Site 13 — Vestal, New York, United States
• Bausch Site 2 — State College, Pennsylvania, United States
• Bausch Site 14 — Brentwood, Tennessee, United States
• Bausch Site 5 — Memphis, Tennessee, United States
• Bausch Site 3 — Nashville, Tennessee, United States
• Bausch Site 15 — New Berlin, Wisconsin, United States

Full record on ClinicalTrials.gov

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