Neurotrophic Keratitis Clinical Trial
Official title:
Randomized, Parallel Groups, Multicenter and Blind to Evaluators Clinical Trial, to Evaluate the Efficacy and Safety of PRGF-Endoret Eye Drops, in Patients With Stage 2 and 3 Neurotrophic Keratitis
Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the regeneration deterioration and development of corneal ulceration, their fusion, and perforation The main characteristic in the NK is a decrease or absence of corneal sensitivity.
The goals of treatment in the neurotrophic keratitis are prevent the progression of corneal
damage, maintain eye structure and improve the transparency of the cornea. Therapy should be
initiated early and based on the clinical stage of the disease because it depends on
epithelial state and in the degree of corneal hypoesthesia.
Plasma rich in growth factors (PRGF-Endoret) represent a new technology using autologous
proteins, growth factors and biomaterials as therapeutic formulations for different
regenerative purposes. Under strict pharmaceutical development, it is possible to develop
biologically stable eye drops, which have been shown to be useful for treating diverse ocular
surface diseases. PRGF-Endoret eye drops could be an alternative therapy for patients with
NK, and thus the objective of this clinical trial is to demonstrate its possible efficacy and
its safety in patients with NK in stages 2 and 3.
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