Sample Size Justification. No formal sample size calculation is provided given the descriptive and pilot nature of the study.
Sample Size Justification. Sample size is based upon the following: • Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses – at least 50 evaluable subjects to be followed for at least 3 months, for claim of substantial equivalence for a lens with different repeating monomer Units (new Parent USAN). In addition, a 2:1 ratio in Test vs Control evaluable subject allocation should be adopted. • ISO 11980:2012 – 50 completed subjects in Test, for 3 months. Either 2:1 or 1:1 ratio of Test to Control can be accepted.
Sample Size Justification. Sample size calculation is based on a prior clinical study which evaluated performance of DT1 and Infuse. Primary Effectiveness To demonstrate noninferiority (margin = 0.05 in logMAR; ½ line in Snellen) in distance VA as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.0497 for paired differences, 80% power can be attained with a sample size of 8 (4 per sequence).
Sample Size Justification. Given the feasibility nature of this study, sample size calculation is not relevant.
Sample Size Justification. For VA with a sample size of 15 in each treatment group, a two-sided 95% confidence interval for the difference of 2 means will extend 0.05 from the observed difference in means with an assumed common standard deviation of 0.07.
Sample Size Justification. Sample size calculations for distance VA at 80% power, are summarized below: Endpoint Assumptions Type I error N Distance VA Habitual lens care and rewetting/lubricating drops as applicable will be used during the wear of habitual lenses. No lens care will be needed during daily disposable study lens (test and control) exposure. Artificial tears and re-wetting drops will not be permitted to be used with study lenses (test and control). Associated materials Contact lens, vision correction, visual acuity, daily disposable contact lens, eye fatigue, digital devices, CVS-Q Key words One-sided 0.05 SD (paired difference) = 0.075 NI margin = 0.05 Primary Table 3–1 Schedule of Study Procedures and Assessments Procedure/ Assessment Pre-screening VISIT 1 VISIT 2 VISIT 3 VISIT 4 Unscheduled Visit Early Exit Day 1 1 Week (7±2 Days) from V1 1 Week (7±2 Days) from V2 1 Week (7±2 Days) from V3 Screening / Fitting / Dispense Optimized Habitual Week 1 Follow-up and Baseline with Optimized Habitual Dispense Study Product 1 Week 1 Follow-up Study Product 1 Dispense Study Product 2 Week 1 Follow-up Study Product 2 / Exit Digital Use Time ✓ - ✓ - ✓ - ✓ - - Symptomatology Question ✓ - ✓ - - - - - - CVS-Q ✓ - ✓ - ✓ - ✓ - - Informed Consent - ✓ - - - - - - - Demographics - ✓ - - - - - - - Habitual Lens (brand and wear schedule), Lens Care, Drops - ✓ - - - - - - - Medical History - ✓ ✓ - ✓ - ✓ ✓ ✓ Concomitant Medications - ✓ ✓ - ✓ - ✓ (✓) ✓ Inclusion/Exclusion - ✓ ✓ - - - - - - VA (OD, OS,OU logMAR distance with habitual contact lenses) - ✓ - - - - ✓ - (✓) Subjective (manifest) refraction* - ✓ (✓) (✓) (✓) (✓) (✓) (✓ ) (✓) BCVA (OD, OS, OU, logMAR distance with manifest refraction)* - ✓ (✓) (✓) (✓) (✓) (✓) (✓ ) (✓) Habitual contact lens power optimization (if needed) - ✓ - - - - - - - Biomicroscopy - ✓ ✓ - ✓ - ✓ (✓ ) ✓ Dispense new (optimized) habitual contact lenses - ✓ - - - - - - - 5 INTRODUCTION
Sample Size Justification. Sample size calculations are based on prior clinical study (CLD523-C001) which evaluated performance of DACP Digital and DACP sphere, preliminary results from IIT #42145213, as well as other publications. Primary Effectiveness To demonstrate noninferiority (margin = 0.05 in logMAR; ½ line in Snellen) in mean distance VA as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.075 for paired differences based on CLD523-C001, 80% power can be attained with a sample size of 16 (8 per sequence). The Study Sponsor may release anonymized study data to external researchers for purposes of future research directly related to the study objectives, or future research that is beyond the scope of the current study objectives. The Informed Consent Form explains this to study subjects. Anonymization means that all identifiable information will be removed from the dataset and all links to the subjects in the study will be removed. Anonymization of the data will maintain confidentiality of the subjects who participate in the study so that they cannot be identified by external researchers. The anonymized data set will contain records from all of the subjects in the current study, but the anonymization process might change the data set in some ways, so external researchers will be informed that they might not be able to duplicate some of the results from this study.
Sample Size Justification. Sample size calculation is based on a prior clinical study (M-14-010) which partly evaluated performance of DACP Multifocal and DACP lenses. To demonstrate noninferiority (margin = 0.05 logMAR) as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.098 for paired differences, 80% power can be attained with a sample size of 36 (18 per sequence group). To demonstrate noninferiority (margin = 1.0) as a one-tailed hypothesis with α=0.05, and using a standard deviation of 2.29 for paired differences, 80% power can be attained with a sample size of 48 (24 per sequence group).
Sample Size Justification. To enroll more than or equal to 30 eligible T2 eyes used for analysis, at least 30 subjects will be evaluated by a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning and unilaterally or bilaterally implanted with the AcrySof IQ PanOptix IOL (TFNT20). Using a new Alcon calculator that incorporates ocular trends in Toric IOL planning, percentage of eyes with ≤ 0.25 D refractive cylinder at Visit 3/3A (Day 30-60) in T2 group was estimated as 60.9% based on a previous (T2) study conducted in US. Using the same calculator, the percentage in T0 group was recalculated as 29.2% from the combined result of studies (non-Toric T0 lenses) conducted in Japan . Statistical test will be conducted to compare percentage of T2 with a constant of 29.2% as percentage of T0. With 30 eyes from 30 subjects in T2 group, assuming the percentage of T2 is equal to 60.9% , the statistical power to demonstrate superiority of T2 to T0 is 91.6% with one-sided alpha of 2.5%, using an exact test of binomial proportion.
Sample Size Justification. The multiplicity adjustment strategy is outlined in Figure 15.-1. Sample size estimations are based on the minimum sample size needed to achieve 90% power for all hypothesis tests. A type I error rate of 2.5%, one-sided, is used for calculations to account for simultaneous testing in Gate 2 (see Figure 15-1). Assuming a dropout rate of 5%, approximately 160 subjects will be bilaterally implanted in 1:1 allocation ratio (test: control) to achieve at least 152 subjects who complete the study. With 152 subjects (76 per group) there is 98% probability that an upper one-sided 97.5% confidence limit on the difference (test-control) in visual acuity will be less than 0.1 logMAR, assuming the mean difference of 0.0 logMAR and a common standard deviation of
