Common use of Treatment Assignment / Randomization Clause in Contracts

Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence of test product then comparator product or comparator product then test product, respectively. Only after signing the ICF at Visit 1, a subject will be assigned a subject number by the electronic data capture system. A randomization list will be generated using a validated system that automates the random assignment of treatment arms to randomization numbers in the specified ratio. Subjects will be assigned treatment according to the randomization list uploaded in the randomization system. The randomization list will be generated and maintained by the study sponsor. At Visit 1, all eligible subjects will be randomized via the EDC/randomization integration system to one of the treatment arms (lens sequences). The investigator’s delegate will access the respective system after confirming that the subject meets all the eligibility criteria. A randomization number will be automatically assigned to the subject according to the subject randomization list but will not be communicated to the site user. The EDC/randomization integration system will inform the site user of the treatment sequence assignment to be dispensed to the subject.

Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 ratio to receive treatment (lens) in crossover sequence of test product DACP FreshTech then comparator product DACP or comparator product DACP then test productDACP FreshTech, respectively. Only after signing the ICF at Visit 1ICF, a subject will be assigned a subject number by the electronic data capture system. A randomization list will be generated using a validated system that automates the random assignment of treatment arms sequences to randomization numbers in the specified ratio. Subjects will be assigned treatment according to the randomization list uploaded in the randomization IRT system. The randomization list will be generated and maintained by the study sponsorStudy Sponsor. At Visit 12, all eligible subjects will be randomized via the EDC/randomization IRT integration system to one of the treatment arms (lens sequences). The investigator’s Investigator or delegate will access the respective system after confirming that the subject meets all the eligibility criteria. A randomization number will be automatically assigned to the subject according to the subject randomization list but will not be communicated to the site user. The EDC/randomization IRT integration system will inform the site user of the treatment sequence assignment to be dispensed to the subject.