A Prospective, Randomized, Doubled-masked, Single Center, Clinical Comparison of Autologous Serum, Heterologous Serum and Umbilical Cord Serum Eye Drops in the Management of Dry Eye Syndrome

INTERVENTION: Product Name: Colirio de sangre de cordón umbilical Pharmaceutical Form: Eye drops INN or Proposed INN: Umbilical Cord Serum Eye Drops Current Sponsor code: COL_SCU Other descriptive name: Suero rico en sustancias lubricantes y nutrientes procedentes de cordón umbilical Concentration unit: % percent Concentration type: equal Concentration number: 20‐ Product Name: Colirio de suero autólogo Pharmaceutical Form: Eye drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: Suero autólogo con sustancias lubricantes y nutrientes Concentration unit: % percent Concentration type: equal Concentration number: 20‐ Product Name: Colirio suero heterólogo Pharmaceutical Form: Eye drops INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: Suero heterólogo con sustancias lubricantes y nutrientes Concentration unit: % percent Concentration type: equal Concentration number: 20‐ CONDITION: Ocular surface disturbances. Therapeutic area: Diseases [C] ‐ Eye Diseases [C11] PRIMARY OUTCOME: Main Objective: To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord therapy in patients with severe dry eye syndrome. ; ; To accomplish clinical comparison of the effects between the three therapies. Primary end point(s): To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome. ; ; To accomplish clinical comparison of the effects between the three therapies. Secondary Objective: PRIMARY OBJECTIVES:; 1) To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome. ; ; 2) To accomplish clinical comparison of the effects between the three therapies.; ; SECONDARY OBJECTIVES:; To determine by ELISA in autologous, heterologous and umbilical cord:; ; 1) Growth factors: EGF, TGF‐? and PDGF. ; 2) Neurotrophic factors: IGF ‐1, P suBstance, ?2 microglobulin and fibronectin. ; 3) Essentials tear components like A vitamina, IgG, lisozima and complement factors. Timepoint(s) of evaluation of this end point: 44 and 74 days SECONDARY OUTCOME: Secondary end point(s): 1) To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome. ; ; 2) To accomplish clinical comparison of the effects between the three therapies.; ; SECONDARY OBJECTIVES:; To determine by ELISA in autologous, heterologous and umbilical cord:; ; 1) Growth factors: EGF, TGF‐? and PDGF. ; 2) Neurotrophic factors: IGF ‐1, P suBstance, ?2 microglobulin and fibronectin. ; 3) Essentials tear components like A vitamina, IgG, lisozima and complement factors. Timepoint(s) of evaluation of this end point: 44 and 74 days INCLUSION CRITERIA: ‐ Dry eye symptoms (red eyes, lid inflammation, discharge, dry eye, sandy and foreign body sensations, burning, itching, discomfort, pricking, tearing and photophobia) for more than three months. ‐ BUT < 5 seconds or ‐ Schirmer Test (tipe I) < 5 mm. ‐ Patients over 18 years old with severe dry eye of all etiologies. ‐ previous signment of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13