Clinical trial NCT04158466: A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
Official title: A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Disposable Contact Lenses
Soft Contact Lens
Soft Contact Lenses
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean logMAR Contact Lens Visual Acuity
timeFrame: 3 months
measure: Proportion of Participants With Slit Lamp Findings Greater Than Grade 2
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Bausch Site 8
state: California
city: San Francisco
country: United States
facility: Bausch Site 9
state: California
city: Torrance
country: United States
facility: Bausch Site 10
state: California
city: Torrance
country: United States
facility: Bausch Site 12
state: California
city: Sarasota
country: United States
facility: Bausch Site 6
state: Florida
city: 'Aiea
country: United States
facility: Bausch Site 4
state: Hawaii
city: Honolulu
country: United States
facility: Bausch Site 16
state: Hawaii
city: Pittsburg
country: United States
facility: Bausch Site 7
state: Kansas
city: Bloomington
country: United States
facility: Bausch Site 11
state: Minnesota
city: Saint Louis
country: United States
facility: Bausch Site 1
state: Missouri
city: Vestal
country: United States
facility: Bausch Site 13
state: New York
city: State College
country: United States
facility: Bausch Site 2
state: Pennsylvania
city: Brentwood
country: United States
facility: Bausch Site 14
state: Tennessee
city: Memphis
country: United States
facility: Bausch Site 5
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 3
state: Tennessee
city: New Berlin
country: United States
facility: Bausch Site 15
state: Wisconsin
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Daniel Donatello
role: STUDY_DIRECTOR
References: