Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time, for reasonable cause. If the clinical study is prematurely terminated or suspended by the Study Sponsor: • The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. o Inform the Investigator and the regulatory authorities of the termination/suspension and the reason(s) for the termination/suspension, as applicable. • The Investigator must: o Promptly notify the IRB of the termination or suspension and of the reasons. o Provide subjects with recommendations for post-study treatment options as needed. The Investigator may terminate a site’s participation in the study for reasonable cause.
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time, for reasonable cause.
Clinical Study Termination. If discontinuation of the entire study has become inevitable for reasons of reports on serious safety information from any participating study site or overseas, problems pertaining to the quality of the investigational lens, and so on, the Sponsor is required to immediately inform the investigator and the head of each study site of discontinuation of the study and its reason in writing.
10.4.1 Follow-up of subjects after study participation has ended
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: • The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. o Inform the Investigator and the regulatory authorities of the termination/suspension and the reason(s) for the termination/suspension. Printed By: Print Date: • Hypopyon • Hyphema • Neovascularization within the central 6 mm of the cornea • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve • Uveitis (anterior, intermediate, or posterior) • Corneal abrasion affecting ≥ 50% of corneal surface area
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: • The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. o Inform the Investigator and the regulatory authorities of the termination/suspension and the reason(s) for the termination/suspension. • Hypopyon • Hyphema • Neovascularization within the central 6 mm of the cornea • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve • Uveitis (anterior, intermediate, or posterior) • Corneal abrasion affecting ≥ 50% of corneal surface area
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: • The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. o Inform the Investigator and the regulatory authorities of the termination/suspension and the reason(s) for the termination/suspension. • The Investigator must: o Promptly notify the IRB/IEC of the termination or suspension and of the reasons. o Provide subjects with recommendations for post-study treatment options as needed. For each recorded event, the ADEs and SAEs documentation must include: date of occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness and causality. In addition, the Investigator must document all device deficiencies reported or observed with test and control products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor immediately as follows: • All SAEs must be reported immediately (within 24 hours) of the Investigator’s or site’s awareness. • ADEs that do not meet seriousness criteria and device deficiencies must be reported within 10 calendar days of the Investigator’s or site’s awareness. • A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or Device Deficiency eCRF must be included with product returns. • Additional relevant information after initial reporting must be entered into the eCRF as soon as the data become available. • Document any changes to concomitant medications on the appropriate eCRFs. • Document all relevant information from Discharge Summary, Autopsy Report, Certificate of Death etc., if applicable, in narrative section of the Adverse Device Effect (for related AEs) and Serious Adverse Event eCRF.
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: • The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. • Hyphema • Neovascularization within the central 6 mm of the cornea • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve • Uveitis (anterior, intermediate, or posterior) • Corneal abrasion affecting ≥ 50% of corneal surface area *NOTE: Culture samples (from the subject’s eyes, lenses, etc) must be taken at investigator’s discretion [as described in the MOP; and documented in the narrative section(s) of the corresponding ADE-SAE eCRF], for any suspected ocular infection, including infiltrates with overlying epithelial defect.
Clinical Study Termination. The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: The Study Sponsor must: o Immediately notify the Investigator(s) and subsequently provide instructions for study termination. o Inform the Investigator and the regulatory authorities of the termination/suspension and the reason(s) for the termination/suspension. The Investigator must: o Promptly notify the IRB/IEC of the termination or suspension and of the reasons. o Provide subjects with recommendations for post-study treatment options as needed. The Investigator may terminate the site’s participation in the study for reasonable cause. Hyphema Neovascularization within the central 6 mm of the cornea Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit (Visit 1) that fails to resolve Uveitis (anterior, intermediate, or posterior) Corneal abrasion affecting ≥ 50% of corneal surface area *NOTE: Culture samples (from the subject’s eyes, lenses, etc) must be taken at Investigator’s discretion [as described in the MOP; and documented in the narrative section(s) of the corresponding ADE-SAE eCRF] for any suspected ocular infection, including infiltrates with overlying epithelial defect.
