Statistical Hypotheses. No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses are formulated.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 for noninferiority: H0: µ(T) – µ(C) ≥ 0.05 Ha: µ(T) – µ(C) < 0.05 where µ(T) and µ(C) denote the mean distance VA for DT1 and Infuse, respectively, on the logMAR scale.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 (in logMAR scale) for noninferiority: H0: μ(T) − μ(C) ≥ 0.10 Ha: μ(T) − μ(C) < 0.10 where μ(T) and μ(C) denote the Week 1 Follow-up mean CLCDVA for contact lenses, respectively, on the logMAR scale. and Biofinity
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 (10%) for noninferiority. H0: P(T) – P(C) ≤ -0.10 Ha: P(T) – P(C) > -0.10 where P(T) and P(C) denote the proportion of subjects attaining at least 20/20 in CLCDVA at Week 1 Follow-up in each eye (OD and OS) for and Biofinity contact lenses, respectively.
Statistical Hypotheses. No hypothesis testing of the primary effectiveness endpoint is planned.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 for noninferiority: H0: μ(DACP D) - μ(DACP) ≥ 0.05 Ha: μ(DACP D) - μ(DACP) < 0.05 where μ(DACP D) and μ(DACP) denote the mean distance VA (in logMAR) for DACP Digital and DACP, respectively.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 for noninferiority: H0: μ(T) - μ(C) ≥ 0.05 Ha: μ(T) - μ(C) < 0.05 where μ(T) and μ(C) denote the mean distance logMAR VA for DACP FreshTech and DACP, respectively, at Week 1 Follow-up. • Device deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of adverse events as well as the other listed parameters. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to IP. Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from baseline (last assessment prior to study lens exposure) to any subsequent visit within the same period will be presented. A supportive listing will be generated which will include all biomicroscopy data from all visits within the same period for those eyes experiencing the increase. Two listings for device deficiencies, prior to exposure of study lenses and treatment- emergent, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Statistical Hypotheses. 24 6.4.1.2 Analysis Methods 24 6.4.2 Secondary Effectiveness 24 6.5 Subgroup Analyses 25 6.6 Handling of Missing Data 25 6.7 Multiplicity 25 6.8 Safety Analysis 25 6.9 Interim Analyses 26 26 7 ADVERSE EVENTS AND DEVICE DEFICIENCIES 26 7.1 General Information 28 7.2 Monitoring for Adverse Events 31 7.3 Procedures for Recording and Reporting 32 7.4 Return product analysis 34 7.5 Follow-up of Subjects with Adverse Events 34 7.6 Pregnancy in the Clinical Study 34 8 CONFIDENTIALITY, BIAS, AND MASKING 34 8.1 Subject Confidentiality and Methods Used to Minimize Bias 34 8.2 Unmasking of the Study Treatment 35 9 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 35
Statistical Hypotheses. The primary analysis will be performed using an exact test of binomial proportion (one-sided alpha = 2.5%). The null (H0) and alternative (H1) hypotheses are; H0: π(T2) = 29.2% H1: π(T2) > 29.2% , where π(T2) is the population proportion of eyes with ≤ 0.25 D refractive cylinder at Visit 3/3A (Day 30-60) for T2 group. The 29.2% is the percentage of non-Toric (T0, hereafter) group estimated from historically combined studies that would have qualified for T2 according to the new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning.
Statistical Hypotheses. No confirmative statistical hypothesis testing is planned for secondary effectiveness variables
