Analysis Methods. A mixed effects repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, period, and sequence. Within-subject correlation due to eye and the crossover design will also be accounted for in the model. Lens difference (PRECISION1 minus Biotrue) and the corresponding one-sided 95% upper confidence limit will be computed. Noninferiority in distance VA will be declared if upper confidence limit is less than 0.05.
Analysis Methods. A binary variable will be defined for each subject to indicate whether the CLCDVA at Week 1 Follow-up is no worse than 20/20 in both OD and OS, and the corresponding proportion will be computed for each lens using the number of subjects as the denominator From the two-sided 95% CI on the lens difference ( minus Biofinity), noninferiority in proportion of subjects achieving 20/20 or better in CLCDVA in both eyes will be declared if the lower confidence limit is greater than -0.10.
Analysis Methods. Analysis methods for sizing shall be consistent with Section 4-8 and standard engineering practice. Imported water shall not be included in the existing runoff from the site. The applicant shall submit clearly labeled calculations including: Hydrologic parameters and source(s) of data Analysis methods used Additional assumptions made (infiltration rates may require field tests, consult Public Works before proceeding) Spreadsheet, printouts, or hand calculations Results (required volume, orifice sizes, stage discharge curve for hydrograph methods, etc.)
Analysis Methods. The primary hypothesis will be tested by generating a two-sided 90% confidence interval using repeated measures analysis of variance at a type I error rate of 5%, 1-sided. Tests at each visit will be reported with Visit 4A (120-180 days) prospectively identified as the primary time point of interest. The upper bound of the two-sided 90% confidence interval will be compared to the margin, 0.
1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TFNT00 IOL will be concluded non-inferior to the 839MP IOL for UCIVA. The two sided 90% confidence intervals will be reported for the difference between the treatment groups at each visit.
Analysis Methods. For the superiority hypothesis tests, treatment group comparison for UCIVA will be made and the first secondary objective will be demonstrated if p<0.025 from a repeated measures analysis of variance at a Type I error rate of 2.5%. Tests at each visit will be reported with Visit 4A (120-180 days) prospectively identified as the primary time point of interest. The two-sided 95% confidence intervals will be reported for the difference between treatment groups at each visit. For the fourth and fifth secondary objectives, superiority will be demonstrated if p<0.05 (or p<0.025, depending on the gatekeeping) for UCNVA and UCDVA at Visit 4A (120-180 days), respectively.
1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCDVA. The two-sided 95% confidence intervals will be reported for the difference between the treatment groups at each visit.
1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCNVA. The two-sided 95% (or 90%) confidence intervals will be reported for the difference between the treatment groups at each visit. Summaries of logMAR visual acuity will also include two-sided 90% confidence intervals. A composite visual acuity endpoint comprising binocular uncorrected visual acuity at Distance (4 m) and Near (40 cm) will be summarized as a categorical variable with the following categories: 20/20 or better (≤0.04 logMAR), 20/32 or better (≤0.14 logMAR) and 20/40 or better (≤0.24 logMAR). Defocus curves will be generated for binocular defocus data, including two-sided 90% confidence intervals, with the amount of defocus along the x-axis and logMAR VA at each defocus point along the y-axis. To examine inter-site variation in outcome, forest plots of near, intermediate and distance visual acuity will be produced by plotting the difference in means and associated standard error for each site. Contrast Sensitivity will be scored and analyzed per contrast sensitivity unit instructions. Responses to the satisfaction question will be analyzed as a categorical variable.
Analysis Methods. A mixed effects repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, visit (Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up), and lens-by-visit interaction as fixed effects, protocol as a random effect and baseline best corrected distance VA as a covariate. Within-subject correlation due to eye will also be accounted for in the model. Lens difference ( minus Biofinity) and the corresponding two-sided 95% CI will be computed for 1-Week Follow-up. Noninferiority in CLCDA will be declared if the upper confidence limit is less than 0.10.
Analysis Methods. Descriptive statistics will be presented, to include frequencies and percentages in each grade
Analysis Methods. A generalized linear model, with a logit link function, accounting for within-subject correlation will be fit. A one-sided 95% upper confidence limit (UCL) will be calculated for the difference in proportions between treatments ( contact lens minus Biofinity contact lens), and the null hypothesis will be rejected if UCL < 0.05.
Analysis Methods. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued analysis sets. A listing containing details of the AEs will also be provided. Each biomicroscopy parameter will be tabulated by its grade, on Completed and Discontinued analysis sets. Frequency for each device deficiency category will be presented and a supporting listing will be provided.
Analysis Methods. A mixed effect repeated measures model will be fit to test these hypotheses, including terms for lens care solution, period, sequence group, and baseline CLDEQ-8 as fixed effects and subject as a random effect. Lens care difference (OFPM minus HMPS) and the corresponding one-sided 95% upper confidence limit will be provided.
