Pro-Ocular™, innovative dry eye treatment
Pro-Ocular™ is a new drug containing a neurosteroid that could become an innovative therapy in the treatment of signs and symptoms of Dry Eye Disease (DED).
SIFI is going to develop Pro-Ocular™ in Europe according with an exclusive partnership agreement with GLIA LLC,
pharmaceutical start-up based in Boston.
Pro-Ocular™ is characterized by a novel dosage delivery system that activates neural signaling to produce endogenous tear film without need for eye instillation.
The outcomes of a Phase II study, carried out in the United States, show that Pro-Ocular™ significantly reduces or eliminates ocular discomfort, dryness, and grittiness. Utilizing the TearScan™ instrument, tear film secretion is observed within minutes in over 95% of subjects following Pro-Ocular™ application.
SIFI is going to carry out either a dose finding phase II and then a final phase III for the product development cycle.
The initial Phase II will take place in Italy and will start between February and March 2020, as soon as approved by AIFA and the local ethical committees.
The clinical trial will be doubled-masked and placebo-controlled, including a group of patients receiving only a placebo (an inert substance or treatment which is designed to have no therapeutic value) and two groups receiving two different concentrations of the active (Pro-Ocular™ 1% and Pro-Ocular™ 0.5%). The patients will be randomly assigned to these groups without having information to which they belong.
Please see below the list of the participating investigational sites who are in charge of patients’ selection according to the eligibility criteria of the clinical protocol and of the overall study conduction.
Should you have any questions or interest, please only refer to doctors/hospitals mentioned below.
Clinical trial sites
Ospedale Luigi Sacco
Via G.B Grassi, 74 - 20157 Milano (MI)
Principal Investigator and National Coordinator: Prof. Stefano Barabino
Largo Brambilla, 3 - 50134 Firenze
Principal Investigator: Prof. Rita Mencucci
A.O.U. Policlinico Gaetano Martino
Via Consolare Valeria - 98125 Messina (ME)
Principal Investigator: Prof. Pasquale Aragona
Ospedale San Marco
Viale Carlo Azeglio Ciampi, 95121 Catania CT
Principal Investigator: Dott.ssa Caterina Gagliano
Dry Eye Disease
Dry Eye Disease (DED) is one of the most frequent causes of patient visits to eye care practitioners, and has become a global unmet need, afflicting over 30 million people in the United States alone and at least 344 million people worldwide.
Dry eye syndrome is growing also among children and adolescents, and the World Health Organization has recently defined it as one of the most ignored and undervalued pathologies of the modern age.
Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.
In addition, activities related to the use of smartphones, tablets and any kind of digital device, if excessive and employed at a very close distance to the eyes, may significantly alter the production of tear film.
See also Dry Eye
, 2018 -“SIFI announces license and development agreement with GLIA LLC on innovative dry eye treatment for Europe”