LIST OF ACRONYMS AND ABBREVIATIONS. Table 2–1 List of Acronyms and Abbreviations Used in This Protocol Abbreviation Definition ADE Adverse device effect AE Adverse event ASADE Anticipated serious adverse device effect BCVA Best corrected visual acuity BI Prism base in BO Prism base out CFR Code of Federal Regulations cm Centimeter CI Confidence intervals COL Clinical Operations Lead CRF Case report form CSM Clinical Site Manager CVS-Q Computer Vision Syndrome Questionnaire D Diopter DACP or DACP contact lenses or DACP sphere DAILIES AquaComfort Plus (nelfilcon A) Soft Contact Lenses DACP FreshTech or DACP FreshTech contact lenses DAILIES AquaComfort Plus (nelfilcon A) FreshTech Soft Contact Lenses DEF Digital Eye Fatigue DEP Deviations and evaluability plan eCRF Electronic case report form EDC Electronic data capture FAS Full analysis set FDA US Food and Drug Administration GCP Good Clinical Practice GPCMS Global Product Complaint Management System HIV Human immunodeficiency virus ICF Informed consent form ICH International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use IEC Independent ethics committee IIT Investigator initiated trial IP Investigational product IRB Institutional review board IRT Interactive response technology ISO International Organization for Standardization Abbreviation Definition LID Lens identification logMAR Logarithm of the minimum angle of resolution m Meter mm Millimeter MOP Manual of procedures N Number of subjects NI Non-inferiority N/A Not applicable OD Right eye OS Left eye OU Both eyes PP Per protocol SADE Serious adverse device effect SAE Serious adverse event SD Standard deviation SOP Standard operating procedure UCL Upper confidence limit US United States USADE Unanticipated serious adverse device effect VA Visual acuity 3 PROTOCOL SUMMARY Investigational product type Device Study type Interventional Investigational products Test Product: DACP FreshTech contact lenses Control Product: DACP contact lenses Purpose and rationale The purpose of this study is to demonstrate noninferiority in distance VA of DACP FreshTech when compared to DACP contact lenses. The rationale for this study to compare the clinical performance of the new DACP FreshTech contact lenses to an already marketed daily disposable contact lens (DACP).
LIST OF ACRONYMS AND ABBREVIATIONS. Table 2–1 List of Acronyms and Abbreviations Used in This Protocol Abbreviation Definition ADE Adverse device effect AE Adverse event ARMD Age-related macular degeneration xx Xxxxxxx CI Confidence interval CRF Case report form D Diopter(s) GCP Good Clinical Practice IB Investigator’s brochure ICF Informed consent form IOL Intraocular lens IOP Intraocular pressure IP Investigational product IRB Investigational review board LASIK Laser-assisted in situ keratomileusis LRI Limbal relaxing incision mm millimeter MOP Manual of procedures PCO Posterior capsule opacification PRK Photorefractive keratectomy SAE Serious adverse event SADE Serious adverse device effect SD Standard deviation SOP Standard operating procedure SSI Secondary Surgical Intervention(s) VA Visual acuity YAG Yttrium aluminum garnet laser
LIST OF ACRONYMS AND ABBREVIATIONS. 3GPP 3rd Generation Partnership Project 5GPPP 5G infrastructure Public Private Partnership ACM Access Control Manager AP Access Point ATPC Automatic Transmit Power Control BiCMOS Bipolar Complementary Metal-Oxide Semiconductor BS Base Station CMOS Complementary Metal-Oxide Semiconductor EC European Commission EMF Electromagnetic Field FD-SOI Fully Depleted Silicon On Insulator FP7 Seventh Framework Program IC Integrated Circuit IoT Internet of Things IPC Institute for Interconnecting and Packaging Electronic Circuits IPR Intellectual Property Rights IQ or I/Q In-phase/Quadrature-phase KPI Key Performance Indicator LCP Liquid Crystal Polymer LTCC Low Temperature Cofired Ceramic LTE Long Term Evolution LTE-A Long Term Evolution Advanced M2M Machine to Machine MSE Mean Square Error mmWave Millimeter Wave PCB Printed Circuit Boards QoS Quality of Service RAN Radio Acccess Network RF Radio Frequency RRH Remote RadioHead Rx Receive SiGe Silicon Germanium SME Small Medium Enterprise SoC System on Chip STO Standardization Office TA Technical Annex Tx Transmit UE User Equipment WP Work Package
LIST OF ACRONYMS AND ABBREVIATIONS. BSC Barcelona Supercomputing Center CF Crop Forcing COD Codorniu DSS Decision Support System IRTA Institue of Agrifood Research and Technology LINKS LINKS Foundation MBD Mastroberardino MET Meteosim NAP University of Naples PAB Project Advisory Board XX Xxxxxxxxx SEM SEMIDE SYM Xxxxxxxxx UNAP University of Naples UPORTO University of Porto WP Work Package
