Clinical Trial: Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Biotechnology Institute IMASD

Current Primary Outcome: Percentage of patients with a reduction of corneal defect of >50% [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of patients with a reduction of corneal defect of >50% [ Time Frame: 2 weeks ]
  • Percentage of patients showing complete healing of the corneal defect [ Time Frame: 4 weeks ]
  • Percentage of patients showing complete healing of the corneal defect [ Time Frame: 2 weeks ]
  • Measurement of the depth of the corneal defect (mm) [ Time Frame: 2 and 4 weeks ]
  • Changes in percentage in Best corrected visual acuity (BCVA LogMAR) [ Time Frame: 2 and 4 weeks ]
  • Ocular pain with VAS scale [ Time Frame: 2 and 4 weeks ]
  • Osmolarity of lacrimal film [ Time Frame: 2 and 4 weeks ]
  • Measurement of treatment tolerance [ Time Frame: 2 and 4 weeks ]
    Measurement of treatment tolerance with a 0 4 score
  • Adverse events [ Time Frame: 2 and 4 weeks ]
    Percentage of adverse event occurrence


Original Secondary Outcome: Same as current

Information By: Biotechnology Institute IMASD

Dates:
Date Received: February 29, 2016
Date Started: March 2016
Date Completion: January 2017
Last Updated: March 11, 2016
Last Verified: March 2016