Study #893 28 June 2019 NCT04901897

Study #89328 June 2019NCT04901897

Study #893 - ProtocolINVESTIGATOR STATEMENT OF APPROVALA Study to Evaluate the Product Performance of a New Silicone Hydrogel ContactLensPROTOCOLSTUDY #893I have read the attached document, concur that it contains all information necessary toconduct the study, and agree to abide by all provisions set forth therein.I agree to conduct this study in accordance with 21CFR Parts 11, 50, 54, 56, 812, and42 USC 282(j); and with consideration of the provision in: ISO 14155-1:2009 Clinicalinvestigation of medical devices for human subjects – Part 1: General requirements; 141552:2009 Part 2: Clinical investigation of medical devices for human subjects – Part 2:Clinical investigational plan; ISO 11980:2009 Ophthalmic Optics – Contact Lenses andcontact lens care products – Guidance for clinical investigations; ICH, GCPs, andapplicable local regulations. I will not initiate the study until I have obtained writtenapproval by the appropriate IRB and have complied with all financial and administrativerequirements of the governing body of the clinical institution and the Sponsor. I will obtainwritten informed consent from each study subject prior to performing any study specificprocedures.I understand that my signature on this document indicates my agreement to this clinicalInvestigational Plan/Protocol and to review and, if appropriate, sign the clinical studyreport.I understand that my e-signature on an electronic case report form indicates that the datatherein has been reviewed and accepted by me.I understand that this document and related information is subject to confidentiality termsfound in my signed Confidentiality or Clinical Services Agreement. I agree to protect theconfidentiality of my patients when allowing the Sponsor of this clinical investigation,and/or relevant regulatory authorities and IRBs, direct access to my medical records forstudy subjects.Principal Investigator, Printed NamePrincipal Investigator, SignatureDateUpon signing, provide a copy of this page to Bausch Lomb and retain a copy for your files.Page 2 of 79

Study #893 - ProtocolPERSONNEL AND FACILITIESNOTE: The information on this page is subject to change. All changes will be provided separately.SponsorBausch Lomb, Inc.1400 North Goodman StreetRochester, NY 14609USBiostatisticsClinical OperationsData ManagementStudy Manager (Primary Study Contact)Clinical Trial MaterialsScientific & Clinical AffairsMedical Monitor (for Safety Reporting)Global Regulatory AffairsPharmacovigilance (not for Safety Reporting)Page 3 of 79

Study #893 - ProtocolSYNOPSISName of Sponsor/Company: Bausch Lomb IncorporatedName of Investigational Product:Test: Bausch Lomb kalifilcon A daily disposable contact lensControls: Johnson & Johnson Acuvue Oasys 1-Day with HydraLuxe (senofilconA) daily disposable contact lens and Alcon DAILIES TOTAL1 (delefilcon A) dailydisposable contact lensesTitle of Study: A Study to Evaluate the Product Performance of a New SiliconeHydrogel Contact LensNumber of Clinical Centers: Approximately 35 investigative sites, United StatesonlyPrimary Objective:The objective of this study is to evaluate the product performance of a new siliconehydrogel daily disposable contact lens, kalifilcon A, compared to the Johnson &Johnson Acuvue Oasys 1-Day with HydraLuxe (senofilcon A) daily disposablecontact lens and Alcon DAILIES TOTAL1 (delefilcon A) daily disposable contactlenses when worn by current soft contact lens wearers on a daily disposable wearbasis.Methodology: The study is evaluating the product performance of a new siliconehydrogel daily disposable contact lens packaged in a unique phosphate bufferedsolution. The silicone hydrogel contact lens infused with a unique phosphate bufferedsolution offers the advantage of a high oxygen material infused with ingredients formoisture retention and osmoprotection designed to promote a consistent level ofhealth of the eye.Approximately 800 subjects (1600 eyes) will be enrolled in this two-week, three arms,randomized, parallel, bilateral, single-masked study at approximately 35 investigativesites in the United States. The study is designed to include habitual wearers of siliconehydrogel lenses. Subjects must habitually wear Alcon’s Air Optix Aqua, Air Optixwith HydraGlyde, Air Optix Night & Day, Bausch Lomb’s PureVision 2, Bausch Lomb ULTRA, CooperVision’s Biofinity, Johnson & Johnson Acuvue Oasys withHydraClear or Acuvue Vita soft contact lenses. Approximately one-quarter of thesubjects enrolled in this study must currently wear the Alcon silicone hydrogel lenses,one-quarter of the subjects must currently wear Bausch Lomb silicone hydrogellenses, one-quarter of the subjects must currently wear CooperVision siliconehydrogel lenses and one-quarter of the subjects must currently wear Johnson &Johnson silicone hydrogel lenses.At the Screening/Dispensing Visit, approximately 400 subjects will be randomized toreceive Bausch Lomb investigational kalifilcon A daily disposable contact lenses(Test), approximately 200 subjects will be randomized to receive Johnson & JohnsonAcuvue Oasys 1-Day with HydraLuxe (senofilcon A) daily disposable contactPage 4 of 79

Study #893 - Protocollenses (Control), and approximately 200 subjects will be randomized to receive AlconDAILIES TOTAL1 (delefilcon A) daily disposable contact lenses (Control).Subjects will be assigned randomization numbers sequentially as they are enrolledand deemed eligible to participate. Randomization will be stratified by investigationalsite. Lenses will be dispensed according to randomization schedules provided to theunmasked designee at each site.Number of Subjects Planned: Approximately 800 subjects (1600 eyes)Diagnosis and Main Criteria for Inclusion: Subjects must be 18 to 40 years old on the date the ICF is signed and have capacityto provide voluntary informed consent. Subjects must be myopic and require lens correction from -0.50 to -6.00 Diopter(D) with 0.25 D steps, in each eye. Subjects must be correctable through spherocylindrical refraction and with softspherical contact lenses to 32 letters (0.3 logarithm of the minimum angle ofresolution [logMAR]) or better (2 meters distance, high-contrast chart) in eacheye. Subjects must be free of any anterior segment disorders. Subjects must be adapted soft contact lens wearers and willing to wear their studylenses for at least 8 hours per day on a daily disposable wear basis forapproximately 2 weeks. Subjects must have access to internet connection and personal email tosend/receive emails. Subjects must habitually wear either Alcon’s Air Optix Aqua, Air Optix withHydraGlyde, 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.Key Exclusion Criteria: Subjects participating in any drug or device clinical investigation within 2 weeksprior to entry into this study (Screening/Dispensing Visit) and/or during the periodof study participation. Subjects who have worn gas permeable (GP) contact lenses within the last 30 daysor who have worn polymethylmethacrylate (PMMA) lenses within the last threemonths. Subjects who have any systemic or ocular disease currently affecting ocular healthin the Investigator’s opinion may have an effect on ocular health during the courseof the study. Subjects using any systemic, topical or topical ocular medications that will in theInvestigator’s opinion, affect ocular physiology or lens performance.Page 5 of 79

Study #893 - Protocol Subjects who currently wear daily disposable, monovision, multifocal, or toriccontact lenses. Subjects with an refractive astigmatism of greater than 0.75 D in either eye. Subjects with anisometropia (spherical equivalent) of greater than 2.00 D. Subjects who are amblyopic. Subjects who have had any corneal surgery (e.g., refractive surgery).Investigational Product, Dosage and Mode of Administration:The investigator or designee will instruct all subjects to adhere to the SubjectInstructions provided with their study contact lenses.In order to ensure that the investigator and site staff remain masked to the study lens,an unmasked designee at each site will be responsible for all study lens accountability,including dispensation and collection of study supplies to subjects.Subjects are to be instructed not to discuss or show the dispensed study lenses to theInvestigator or masked site staff during the study.Subjects will be instructed that other contact lenses (other than the study lenses) andcontact lens care products (other than the drops provided) are not allowed to be usedduring the study period.Study Duration of Treatment: approximately 2 weeksCriteria for Evaluation:The primary endpoints are as follows:Effectiveness:The primary effectiveness endpoints to be evaluated at the 2-Week Follow-Up Visitare as follows: Mean logMAR contact lens visual acuity at the 2-Week Follow-Up Visit Proportion of subjects in the Test lens group agreeing with the statement “Arecomfortable throughout the day” Proportion of subjects in the Test lens group agreeing with the statement“Provide clear vision throughout the day”Page 6 of 79

Study #893 - Protocol Safety:The primary safety endpoint will be the proportion of subjects with slit lamp findingsgreater than Grade 2 at any follow-up visit.Statistical Methods:Continuous data will be summarized using descriptive statistics: sample size (n),mean, standard deviation (SD), median, minimum and maximum. Categorical datawill be presented using the total counts for each category and correspondingpercentages. The denominator for each percentage will be the number of subjects oreyes with non-missing data at the given visit for each respective study treatment,unless otherwise indicated.Monocular contact lens logMAR visual acuity will be compared between the test lensand each comparator using a one-sided two-sample t-test and a non-inferiority marginof 0.06.The proportions of subjects agreeing with each of two statements on the subjectquestionnaires will be compared to 0.5 (50%) using one-sided χ2 tests.The proportion of eyes with slit lamp findings greater than Grade 2 at the follow-upvisit will be compared between the test lens and each comparator using confidencelimits constructed using the Newcombe-Wilson score method and a non-inferioritymargin of 0.05 (5%).If the test lens is statistically successful in all primary endpoints, then the test lens willbe statistically successful overall.Sample Size Calculations:Assuming that the test is identical in performance to each comparator for all primaryendpoints, that the primary endpoints are independent, and that the assumptions usedin each power calculation are correct, the overall power of the trial is greater than90%.Page 7 of 79