Treatment masking. This study is double-masked, with subjects randomized to use DD T2 or DT1 soft contact lenses for the duration of the 3-month treatment period. Table 9–3 Unmasked Individuals Associated with the Study Unmasked Individual Extent of Unmasking Rationale Unmasked Study The Unmasked Study The Unmasked Study Coordinator(s) Coordinator(s) will manage IP Coordinator(s) will be inventory, as well as IP unmasked to allow for administration. This individual processing of IP shipment, will have access to IP supply, storage, and dispensing, as accountability logs, and other well as accountability for all documents or supplies IP. pertaining to IP. The unmasked coordinator will also assist with device Unmasked Individual Extent of Unmasking Rationale deficiency and adverse event reporting. LCSM The LCSM will have access to IP supply, accountability logs, and other documents or supplies pertaining to IP. This individual assists with masked and unmasked data reviews. The LCSM will be unmasked to allow for oversight of the CSM, in conjunction with all IP accountability tasks. CSM CSM will have access to IP supply, accountability logs, and other documents or supplies pertaining to IP accountability. This individual monitors unmasked and masked study data. The CSM will be unmasked to allow for performance of IP accountability, management of device deficiencies and related AE lens returns, and any other IP related tasks. Unmasked Data Manager(s) The Unmasked Data Manager(s) will have access to restricted fields in RAVE that would contain unmasking data. The Unmasked Data Manager(s) will be unmasked to allow for review of all restricted data. IRT Manager The IRT manager will be unmasked to allow for system programming, testing, and to allow for technical oversight of the system. The IRT manager is unmasked to all aspects of the trial for system development purposes. Randomization Specialist The Randomization Specialist will be unmasked to allow for generation of the randomization list and uploading of that list into the IRT system. Generates and therefore has full knowledge of treatment codes but otherwise is operationally not associated with the CTT or any decision- making aspects related to clinical trial design, execution, or reporting. Alcon - Business Use Only Protocol - Clinical Effective Date: 24-Aug-2017 Document: TDOC-0054027 Status: Effective Version: 1.0; CURRENT; Most-Recent; Effective Page 33 of 52
Treatment masking. This study is double-masked, with subjects randomized in a 1:1 ratio to receive Toric and Biofinity Toric contact lenses in a crossover sequence for the duration of the two 30-day treatment period. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. In the event of a medical emergency where the knowledge of subject treatment is required, an individual investigator will have the ability to unmask the treatment assignment for a specific subject after contacting an appropriate study sponsor representative if time allows.
Treatment masking. This study is double-masked, with subjects randomized to use the PRECISION1 contact lenses and the Clariti 1-Day contact lenses for the duration 1-week treatment period, per lens type. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked.
Treatment masking. This study is double-masked, with subjects randomized to use or Biofinity contact lenses for the duration of the 3-month treatment period. All members associated with the study (at the site and the Study Sponsor) will be masked to the assigned treatment . This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. In the event of a medical emergency where the knowledge of subject treatment is required, individual Investigator(s) will have the ability to unmask the treatment assignment for a specific subject. If time allows, the appropriate Study Sponsor representative should be contacted prior to unmasking. Unmasking must be done according to the instructions provided for the study IRT system.
Treatment masking. This study is double-masked, with subjects randomized to use DACP Digital and DACP lenses (in a crossover fashion) for the duration of the 7 ± 2 day treatment period for each lens product. . This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the study. In the event of a medical emergency where the knowledge of subject treatment is required, an individual Investigator will have the ability to unmask the treatment assignment for a specific subject after contacting an appropriate Study Sponsor representative if time allows. Unmasking must be done according to the instructions provided for the study IRT system.
Treatment masking. This study is double-masked. All members associated with the study (at the site and the study sponsor) are masked to the assigned treatment This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. In the event of a medical emergency where the knowledge of subject treatment is required, an individual investigator will have the ability to unmask the treatment assignment for a specific subject after contacting an appropriate study sponsor representative if time allows.
Treatment masking. This study is double-masked, with subjects randomized to use lenses for the duration of the 3-month treatment period. or Biofinity contact
