Wirta, David
Lipsky, William
Toyos, Melissa
Martel, Joseph
Goosey, John
Verachtert, Anthony
El-Harazi, Sherif
Karpecki, Paul
Allegretti, Marcello
Goisis, Giovanni
Pasedis, Georgea
Mantelli, Flavio
Article History
Received: 8 August 2023
Accepted: 8 July 2024
First Online: 17 July 2024
Declarations
:
: Institutional Review Board (IRB) approval was obtained for the study protocol, protocol amendments, informed consent forms, and any other relevant study-related documents at each study site (Advarra was the IRB that approved the protocol at all study sites; IRB Registration Number 00000971): SSU00081622 (The Eye Research Foundation); SSU00081999 (Moyes Eye Center); SSU00081991 (Toyos Clinic); SSU00091653 (Tauber Eye Center); SSU00087179 (Sierra Clinical Trials); SSU00082283 (Martel Eye Medical Group); SSU00084542 (Intouch Clinical Research Center); SSU00082110 (Clayton Eye Clinical Research, LLC); SSU00111605 (Kentucky Eye Institute); SSU00082394 (Houston Eye Associates); SSU00097413 (Global Research Management). The study complied with the Declaration of Helsinki, relevant parts of the Code of Federal Regulations Title 21, and good clinical practice and good laboratory practice guidelines. Written informed consent was obtained from all patients before study initiation.
: Not applicable.
: DW has received financial support from Dompé farmaceutici S.p.A. MT has served as a consultant/contractor for Bausch, Dompé farmaceutici S.p.A, Mallinckrodt, Sun, Zeiss, Lumenis, RVL, and Oyster Point and has received financial support from Allysta, Bausch, Dompé farmaceutici S.p.A, Glaukos, Mallinckrodt, Sun, Zeiss, Greenlight, Lumenis, RVL, Novartis, Allysta, and Recordati. WL, JM, JG, AV, SE-H, and PK have no competing interests. GG was an employee of Dompé farmaceutici S.p.A. at the time of this study but is no longer affiliated with the company. MA, GP, and FM are employees of Dompé farmaceutici S.p.A.