A Study to Evaluate the Safety and Efficacy of Kalifilcon... | NCT04158466

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kalifilcon A Daily Disposable Contact Lenses	Experimental	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.	Device: Kalifilcon A Daily Disposable Contact Lenses
Biotrue ONEday Daily Disposable Contact Lenses	Active Comparator	Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.	Device: Biotrue ONEday Daily Disposable Contact Lenses

Name	Type	Description	Arm Group Labels	Other Names
Kalifilcon A Daily Disposable Contact Lenses	Device	Contact lens	Kalifilcon A Daily Disposable Contact Lenses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean logMAR Contact Lens Visual Acuity	Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.	3 months
Proportion of Participants With Slit Lamp Findings Greater Than Grade 2	During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.	3 months

Eligibility Module

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.

Name	Affiliation	Role
Daniel Donatello	Bausch & Lomb Incorporated	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Bausch Site 8		Los Angeles	California	90012	United States
Bausch Site 9

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Kalifilcon A Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 9, 2019

Arm/Group Information

ID	Title	Description
BG000	Kalifilcon A Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens
BG001	Biotrue ONEday Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000124 BG001127 BG002251

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean logMAR Contact Lens Visual Acuity

Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.

The per protocol population consisted of randomized without important (major) protocol deviations. It is a subset of the participants randomized and treated.

Posted

Least Squares Mean

Standard Error

units on a scale

3 months

eyes

ID	Title	Description
OG000	Kalifilcon A Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens
OG001	Biotrue ONEday Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens

Units	Counts
Participants	OG000120 OG001127
eyes	OG000240 OG001

Title

Denominators

Categories

Title	Measurements
	OG000-0.066± 0.0034 OG001-0.060± 0.0032

Primary

Proportion of Participants With Slit Lamp Findings Greater Than Grade 2

During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.

Posted

Count of Units

eyes

3 months

eyes

ID	Title	Description
OG000	Kalifilcon A Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens
OG001	Biotrue ONEday Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Kalifilcon A Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens	0	124	0	124	0	124
EG001	Biotrue ONEday Daily Disposable Contact Lenses	Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens	0	127	0	127	0	127