Study Prospective Randomized Controlled Double-Blind: Comparison of tear substitute (Siccafluid) and Autologous Serum in Dry Eye Disease - Siccafluid and autologous serum

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA0 个研究点开始时间: 2012年10月25日最近更新: 2014年2月3日

适应症

试验速览

暂无简介。

•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

•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

发起方

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA