Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
Condition: Dry Eye; Sjogren Syndrome
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus
      Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.
    

Detailed description: 
      Sjogren syndrome is a chronic autoimmune disorder characterized by immune cell infiltration
      of exocrine glands (exocrinopathy or epitheliitis) and systemic complications due to
      autoantibody production, immune complex deposition and lymphocytic infiltration of many
      organs .The loss of aqueous tear flow in Sjogren syndrome is a result of inflammatory cell
      infiltration of the lacrimal glands.The principal ocular manifestation of which is decreased
      tear production leading to chronic irritation and damage to the corneal and conjunctival
      epithelium. Dry eye associated with Sjogren syndrome (SS dry eye) is often more severe than
      non-Sjogren dry eye (non-SS dry eye). Rose bengal staining, fluorescein staining, impression
      cytology, and brush cytology show greater changes in SS dry eye owing to a lack of both basic
      tearing and reflex tearing resulting from lacrimal gland destruction, which is the hallmark
      of deteriorating clinical conditions.

      The initial tear film ocular surface society dry eye workshop report noted the importance of
      ocular surface inflammation not only in the development of, but as a downstream effect and
      propagator of dry eye disease , and reviewed a range of therapies that function, at least in
      part, by anti-inflammatory mechanisms of action. Thus understanding the link between
      inflammation and dry eye validates the utilization of anti-inflammatory therapy in everyday
      practice.

      Cyclosporine is understood to be an immunomodulatory drug with anti-inflammatory properties,
      as well as having other actions relevant to managing dry eye disease . Topical cyclosporine
      was approved by the FDA for the treatment of moderate-to-severe dry eye disease in 2003,
      based on an improvement in tear production.

      Tacrolimus, a macrolide produced by Streptomyces tsukubaensis,was discovered in 1984 in Japan
      while searching for new immunosuppressive and cancer chemotherapeutic agents. The use of
      tacrolimus is of special interest in ophthalmology because it is indicated to be effective in
      the treatment of immune-mediated diseases Thus, the investigators performed this study to
      evaluate the effect of two different immunomodulatory eye drops on the ocular surface which
      are topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye
      drops in treatment of dry eye in Secondary Sjogren Syndrome.
    

Intervention name(s): Cyclosporins; Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporins eye drops to be administered in dry eyes; Tacrolimus eye drops to be administered in dry eyes
Other intervention name(s): Restasis; FK506
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sjogren Syndrome; Dry eye; Cyclosporine; Tacrolimus