Hamrah, Pedram
Massaro-Giordano, Mina
Schanzlin, David
Holland, Edward
Berdy, Gregg
Goisis, Giovanni
Pasedis, Georgea
Mantelli, Flavio
Clinical trials referenced in this document:
Documents that mention this clinical trial
Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO)
https://doi.org/10.1007/s40123-023-00866-y
Article History
Received: 8 September 2023
Accepted: 24 November 2023
First Online: 4 January 2024
Declarations
:
: Pedram Hamrah has received financial support from CooperVision, Dompé farmaceutici S.p.A., Novartis, Ocular Therapeutix, and OKYO Pharma and has served as a contractor/consultant for Dompé farmaceutici S.p.A., Kala Pharmaceuticals, Novaliq, Novartis, OKYO Pharma, and Oyster Point Pharma. Mina Massaro-Giordano has served as a consultant for Claris Bio, Dompé farmaceutici S.p.A., Kala Pharmaceuticals, Lynthera, Oyster Point, and Tarsus. David Schanzlin has no conflicts of interest to disclose. Edward Holland has served as a consultant for Alcon. Gregg Berdy has served as a researcher for Aerie (now Alcon), Alcon, Allakos, Allergan/AbbVie, Bausch + Lomb, ClarisBio, Dompé, Kala, Novaliq (now Bausch + Lomb), Tarsus, Tear Care, Tear Film Innovations, and Tear Solutions; has consulted for Aerie (now Alcon), Alcon, Allergan/AbbVie, Bausch + Lomb, Dompé, Novartis, Sun, Tarsus, Tear Care, and Tear Solutions; and has lectured for Aerie (now Alcon), Alcon, Allergan/AbbVie, Bausch + Lomb, Dompé, Novartis, Sun, Tarsus, and Tear Care. Giovanni Goisis was an employee of Dompé farmaceutici S.p.A. at the time of this study but is no longer affiliated with the company. Georgea Pasedis and Flavio Mantelli are employees of Dompé farmaceutici S.p.A.
: Institutional review board approval was obtained for the study protocol, protocol amendments, informed consent forms, and any other relevant study-related documents at each center (Sterling IRB, 8203-DJSchanzlin, 8203-EJHolland, 8203-GJBerdy, 8203-MMassaroGiordano; and WCG-WIRB, 20202809). 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.