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Clinical Investigation of Visual Function After Bilateral Implantation

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Clinical Investigation of Visual Function After Bilateral Implantation $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of D1RYDUWLVFRPSDQ\ Clinical Trial Protocol &OLQLFDO,QYHVWLJDWLRQRI9LVXDO)XQFWLRQ$IWHU%LODWHUDO,PSODQWDWLRQRI 7ZR3UHVE\RSLD&RUUHFWLQJ7ULIRFDO,2/V Protocol Number: ILH297-P0031&7 Sponsor Name & Address: Alcon Research, Ltd. and its affiliates (“Alcon”) 6201South Freeway Fort Worth, Texas 76134-2099 Project Name / Number: PanOptix Comparative Study / A02622 Test Article(s) / Product(s): ACRYSOF®IQ PanOptix™ Presbyopia-Correcting IOLModel TFNT00 Release Date: Refer to e-signature date Investigator Agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Principal Investigator: Signature Date Principal Investigator Name: Principal Investigator Address: 3URSHUW\RI$OFRQ/DERUDWRULHV &RQILGHQWLDO 0D\QRWEHXVHGGLYXOJHGSXEOLVKHGRURWKHUZLVHGLVFORVHGZLWKRXWWKHFRQVHQWRI$OFRQ /DERUDWRULHV Printed By: Print Date: $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of 35272&2/6<1236,6 Financial Disclosure for US FDA Yes X No Submission Required? Test Article(s) / The ACRYSOF IQ PanOptix Presbyopia-Correcting IOL Model Product(s): TFNT00 is a single-piece ultraviolet and blue light filtering foldable multifocal IOL. The biconvex optic is 6.0 mm in diameter and the lens has an overall diameter of 13.0 mm. The multifocal optic diffractive structure is in the central 4.5 mm portion of the anterior surface of the optical zone and divides the incoming light to create a +2.17 D intermediate and a +3.25 D near add power (IOL plane). The anterior surface is designed with 0.10 microns of negative spherical aberration to compensate for the positive spherical aberration of the average human cornea. This IOL is intended for primary implantation in the capsular bag in the posterior chamber for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. Objective(s): 3ULPDU\2EMHFWLYH To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix presbyopia-correcting IOL Model TFNT00 to the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected LQWHUPHGLDWH (60 cm) visual acuity at Visit 4A 6HFRQGDU\2EMHFWLYHV 1. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL versus the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected LQWHUPHGLDWH (60 cm) visual acuity at Visit 4A 2. To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix IOL versus the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected GLVWDQFH(4 m) visual acuity at Visit 4A 3. To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix IOL versus the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected QHDU (40 cm) visual acuity at Visit 4A 4. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL versus the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected QHDU (40 cm) visual acuity at Visit 4A. 5. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL versus the AT LISA tri IOL Model 839MP in mean photopic binocular uncorrected GLVWDQFH (4 m) visual acuity at Visit 4A 6. To FKDUDFWHUL]H the binocular defocus curve profiles, contrast sensitivity and patient satisfaction with ACRYSOF IQ PanOptix Printed By: Print Date: $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of IOL versus the AT LISA tri IOL Model 839MP at Visit 4A Clinical Trial Design: This study is a prospective, multi-center, randomized, double masked, parallel group postmarket trial. a) Required for statistical analysis: 152 evaluable completers No. of Subjects: b) Successfully screened: Approximately 180 c) Bilaterally Implanted: Approximately 160 Region(s): Asia, EU, LACAR Clinical Trial a) Total expected duration of the clinical investigation: 13 months Duration: b) Expected duration of each subject's participation: ~7 months c) Planned follow up duration: 6-months post 2nd eye implantation d) Estimated time needed to select the number of subjects (ie, enrollment period): 6 months Clinical Trial Adults subjects, 22 years of age or older, with no ocular pathology Population: that confound study outcomes, who require cataract extraction by phacoemulsification and desire an IOL that provides the potential for near, intermediate and distance vision. Treatments: 7HVW$UWLFOH: ACRYSOF IQ PanOptix Presbyopia- Correcting IOL Model TFNT00 Administration: Routine small incision cataract surgery with IOL implantation. General Description: A range of commonly utilized spherical powers (diopters) will be available. Duration of Intraocular lenses are implantable medical Treatment: devices and are intended for long term use over the lifetime of the cataract subject. &RQWURO$UWLFOH AT LISA tri IOL Model 839MP Administration: Routine small incision cataract surgery with IOL implantation. General Description: A range of commonly utilized spherical powers (diopters) will be available. Duration of Intraocular lenses are implantable medical Treatment: devices and are intended for long term use over the lifetime of the cataract subject. Inclusion & Exclusion Details can be found in Section 10: Subject Population Criteria: Intermediate Visual Acuity Performance x Assessments x Binocular uncorrected intermediate VA (60 cm) Printed By: Print Date: $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of Distance Visual Acuity x x Binocular uncorrected distance VA (4 m) Near Visual Acuity (VA) x x Binocular uncorrected near VA (40 cm) Adverse Events (AEs) including secondary surgical intervention (SSI) Device Deficiencies (DD) Surgical Problems Intraocular Pressure (IOP) Safety Slit Lamp Examination Assessments IOL Observations IOL Position Change Subjective Posterior Capsule Opacification (PCO) Posterior Capsulotomy Fundus Visualization Dilated Fundus Examination Photopic Pupil Size Binocular Uncorrected Defocus Curve Binocular Contrast Sensitivity Other x Photopic without Glare Assessments x Photopic with Glare x Mesopic without Glare x Mesopic with Glare Subject Satisfaction Analyses: A total of six hypothesis tests will be conducted to address the primary and secondary objectives of the study. The primary, second secondary and third secondary will be tests of non-inferiority while the first secondary, fourth secondary and fifth secondary will be tests of superiority. Planned Non-inferiority, with a non-inferiority margin of 0.1 logMAR, will be Analyses: tested for the mean binocular uncorrected photopic visual acuity at each of the following distances, respectively: x Intermediate (60 cm) (primary) x Distance (4 m) (second secondary) x Near (40 cm) (third secondary) Printed By: Print Date: $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of Superiority will be tested for the mean binocular uncorrected photopic visual acuity at each of the following distances, respectively: x Intermediate (60 cm) (first secondary) x Near (40 cm) (fourth secondary) x Distance (4 m) (fifth secondary) Hypothesis testing will be conducted in the order presented above for both non-inferiority and superiority. A combination of gate-keeping and Bonferroni adjustment strategies will be employed to control the overall type I error rate. Descriptive statistics generated for safety and performance parameters will be based upon the type of parameter (ie, whether the data are categorical or continuous) being analyzed and by 1st and 2nd operative eyes for monocular measures. For categorical parameters, the statistics used to summarize the data descriptively include sample size, number in the category, and percent in the category. For continuous parameters, sample size, mean, median, standard deviation, minimum, and maximum will be presented. Summaries of logMAR visual acuity will also include two-sided 90% confidence intervals. Responses to the satisfaction question will be analyzed as a categorical variable. Contrast sensitivity will be scored and analyzed per CSV- 1000E instructions. Defocus curves will be generated for binocular defocus data, including 90% confidence intervals, with amount of defocus along the x-axis and logMAR VA at each defocus point along the y-axis. To examine the inter-site variation in outcome, a forest plot will be produced by plotting the difference in means and associated standard error for each site. An interim analysis will be performed when all subjects complete Visit 3A (20-40 days post 2nd eye implantation) in order to support the study publication plan of the test articles for near, intermediate and distance visual acuity, contrast sensitivity, defocus curves and adverse events. Printed By: Print Date: $OFRQ %XVLQHVV8VH2QO\ Protocol - Clinical (IIHFWLYH'DWH24-Feb-2016 'RFXPHQWTDOC-0051465 9HUVLRQ2.0; Most-Recent; Effective; CURRENT 6WDWXVEffective Page of The interim analysis results will be distributed to a limited audience
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