Study that will compare a tear substitute (Siccafluid) with autologous serum (from the blood of the subject) in the pathology of dry eye, according to a plan that neither the doctor nor the patient will know which treatment the patient is assigned.

• Conditions: Dry eye disease; MedDRA version: 14.1Level: LLTClassification code 10018728Term: Gritty eyesSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-004605-27-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-25
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 - Presence of altered cornea (punctate keratopathy) and / or conjunctival least grade I ° according to the classification scheme of Oxford (Annex A) after staining with fluorescein to the cornea and conjunctiva with lissamine green for.

2 - Tear break-up time fluorescein <10 sec (established cut-off for the diagnosis of dry eye by Lemp and Hamill in 1973)

3 - Presence of dry eye caused by:

• by reduction of tear production (Aqueous Deficient Dry Eye ADDE) and comprises:
• dry eye associated with Sjogren's syndrome
• Primary: presence of ADDE in combination with the symptoms of dry mouth, presence of autoantibodies, evidence of reduced salivary secretion and score positive on biopsy of a minor salivary gland.
• Secondary: combines the features of primary SS with features of autoimmune connective tissue disease a clear (RA, systemic lupus erythematosus, polyarteritis nodosa, Wegener's granulomatosis, systemic sclerosis, primary biliary sclerosis)
• dry eye not associated with Sjögren's syndrome:
• for primary and secondary deficiencies of the lacrimal gland
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

a. duct obstruction of the lacrimal gland
b. causes of increased tear evaporation causes intrinsic
c. Systemic use of drugs that could affect the tear film, tear secretion or the surface area of ??the eye (eg pilocarpine).
d. The use of previous or concurrent topical medications that may affect the evaluation of the drug's
and. History of previous ocular surgery, including refractive surgery, eyelid surgery or corneal surgery.
f. extrinsic causes (disorders of the ocular surfaces, use of contact lenses, allergic conjunctivitis)
g. Contraindications to the use of autologous serum: Hemoglobinopathies with high levels of bilirubin, viral and fungal infections bacterial active; Paraproteinemie; postivi Serology tests (HIV, HCV, HBV).
h. Age <18 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified