Sample Size Justification. No formal sample size calculation is provided given the descriptive and pilot nature of the study.
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. Primary Effectiveness
Sample Size Justification. Sample size calculation for each of the relevant efficacy endpoints is described below. Sample size calculation for the primary efficacy hypothesis on decrease in symptomatology is based on published data (Chalmers 2012). With an assumed SD for paired differences of 10, a sample size of 36/sequence will provide 80% power to detect a difference of 3 at one-sided α=0.05.
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. Sample size calculation is based on a prior clinical study which evaluated performance of DT1 and Infuse. 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. Sample size calculation is based on published results regarding response time for distance and near visual acuity, with high and low contrast. To demonstrate noninferiority (margin = 0.5 seconds) as a one-tailed hypothesis with α = 0.05, and using a common standard deviation of 0.456, 80% power can be attained with a sample size of 48 (12 per group). For a comparison using a 3:1 ratio, required sample sizes for 80% power are 24:8 (test:control).
Sample Size Justification. Sample size calculation was based on extended wear clinical studies from three PMA studies and one 52-week extended wear study that evaluated 5 currently marketed silicone hydrogel contact lenses. The weighted average, based on sample size, on the proportion of ocular serious and significant non-serious ADEs obtained from these five contact lenses was 0.045. Therefore, assuming that the expected difference between test and control is 0 and that the control proportion is 0.045, a sample size of 213 per group will provide 80% power to reject the null hypothesis of inferiority in test compared to control, with a noninferiority margin of 0.05 (5%). Taking into consideration the exposure duration of 12 months, approximately 568 subjects will be randomized (284 test and 284 control) to compensate for approximately 25% drop-out rate.
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. 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.
