Ocular surface disturbances.
Conditions
Interventions
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
Sponsors
FUNDACION IMABIS
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1) Eye-infection or inflammation not related to the dry eye. 2) Contact lens users. 3) Ocular allergy in the past three months. 4) Eyelid and eyelashes malpositions. 5) Pregnant women 6) Positive infectious diseases (haepatitis B and C, HIV and syphilis. 7) Patients with problems related to blood extraction. 8) Patients that have in a clinical trail 30 days prior to the inclusion, in which there has been topical therapy. 9) Patients with chronical therapy with topical corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;Timepoint(s) of evaluation of this end point: 44 and 74 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactINVESTIGACION
HOSPITAL RU CARLOS HAYA
Outcome results
None listed