Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 manner to receive one of 2 lens sequences: Sequence 1 DT1/Infuse Sequence 2 Infuse/DT1 Only after signing the ICF, 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 (lens sequence) to randomization numbers in the specified ratio. Subjects will be assigned treatment (lens sequence) 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 treatments (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 (lens sequence) assignment to be dispensed to the subject.
Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 manner to receive either the contact lenses, respectively. or Biofinity Only after signing the ICF, 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 a treatment arm according to the randomization list uploaded in the IRT 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/IRT integration system to one of the treatment arms. 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/IRT integration system will inform the site user of the treatment assignment to be dispensed to the subject.
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: Test product then Comparator product or Comparator product then Test product, respectively. Sequence EDC/randomization integration system Lens Name Sequence 1 PRECISION1/Biotrue Sequence 2 Biotrue/PRECISION1 Only after signing the ICF, 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 treatments (lens sequence) to randomization numbers in the specified ratio. Subjects will be assigned treatment (lens sequence) 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. The 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 integration system will inform the site user of the treatment (lens sequence) assignment to be dispensed to the subject.
Treatment Assignment / Randomization. Only after signing the ICF, a subject will be assigned a subject number by the electronic data capture system. The investigational product will be placed within the capsular bag after removal of the natural crystalline lens. When both eyes are eligible, the eye which has smaller anticipated residual refractive astigmatism based on a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning shall be the first eye, and the eye which has lager anticipated residual refractive astigmatism shall be the second eye. If both eyes have same anticipated residual refractive astigmatism, the eye with advanced cataract shall be the first eye and the fellow eye should be the second eye.
Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence DACP Digital then DACP or DACP then DACP Digital respectively. Only after signing the ICF, 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 iMedidata BALANCE system. The randomization list will be generated and maintained by the Study Sponsor.
Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 ratio to receive treatment with Test product then Control product or Control product then Test product, respectively. Only after signing the ICF, 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 treatments (lens sequence) to randomization numbers in the specified ratio. Subjects will be assigned treatment (lens sequence) 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 treatments (lens sequence). The investigator or delegate will access the respective system after confirming that the subject meets all the eligibility criteria. The EDC/randomization integration system will inform the site user of the treatment (lens sequence) assignment to be dispensed to the subject.
Treatment Assignment / Randomization. Subjects will be randomized in a 2:1 manner to receive either the or Biofinity contact lenses, respectively. Document: TDOC-0057524 Status: Effective Page 38 of 62 Printed By: Print Date: Document: TDOC-0057524 Status: Effective
10.1 Informed Consent and Screening
Treatment Assignment / Randomization. Subjects will be randomized in a 2:1 ratio to receive either DD T2 or DT1 soft contact lenses, respectively. Only after signing the ICF, 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 iMedidata BALANCE 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/IRT integration system to one of the treatment arms. The 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/IRT integration system will inform the site user of the treatment assignment to be dispensed to the subject.
Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 ratio to receive treatment with or Biofinity in one eye and the other lens in the fellow eye, as indicated below: Sequence 1: (OD)/Biofinity (OS) Sequence 2: Biofinity (OD)/ (OS) Only after signing the ICF, 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 a treatment (lens sequence) 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 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 (lens sequence) assignment to be dispensed to the subject. • All unused products (supplied by the Study Sponsor) are available for return to the Study Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related AE (ie, ADE or SADE) are returned to the Study Sponsor for investigation, unless otherwise directed by the Sponsor. Refer to Section 11 of this protocol for additional information on the reporting of device deficiencies and AEs. Refer to the MOP for the return of study products associated with these events. The Investigator is responsible for proper disposition of all unused IPs at the conclusion of the study, according to the instructions provided in the MOP.
