Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 3

Summary: 
      Since the initial description, the therapeutic efficacy of CsA for human KCS has been well
      documented, with evidence ranging from several small single center randomized double-masked
      clinical trials to several large multicenter randomized, double-masked clinical
      trials.(10-12) Therefore, the aim of the work is to evaluate the effect of using topical CsA
      in treatment of moderate to severe dry eye.
    

Detailed description: 
      Dry eye disease (DED) is known to be among the most frequently occuring ocular morbidities.
      It is a growing public health concern affecting 25% of patients who visit ophthalmic
      clinics.For many years, DED was considered to be limited to dryness of the eyes due to
      decrease in the aqueous phase in the tear film. In 2007, the International Dry Eye Workshop
      discussed the definition and classification of DED and developed a new vision for the
      definition and the three-part classification of DED on the basis of etiology, mechanism, and
      severity of DED. Moreover, DED can be episodic or chronic. Episodic DED occurs when
      environmental or visual tasks with reduced blinking overwhelm the stability of the tear and
      produce symptomatic DED. Chronic DED, although aggravated by the same environmental
      conditions, persists continuously with symptoms and possible damage to the ocular surface.
      Because the tear film in DED patients is not stable and incapable to maintain the protective
      qualities that are important for its structure and function, patients usually experience the
      discomfort manifestations associated with DED such as burning, stinging, foreign body
      sensation, ocular fatigue, grittiness, tearing, and dryness. Patients may complain of
      symptoms of DED in the presence or absence of the known signs and DED may be diagnosed based
      only on the signs observed by a healthcare professional in the absence of symptoms reported
      by the patients.Since the initial description, the therapeutic efficacy of CsA for human KCS
      has been well documented, with evidence ranging from several small single center randomized
      double-masked clinical trials to several large multicenter randomized, double-masked clinical
      trials.Therefore, the aim of the work is to evaluate the effect of using topical CsA in
      treatment of moderate to severe dry eye.
    

Intervention name(s): Topical Cyclosporine A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In our study we used 0.05% CsA prepared in castor oil by transferring (20ml ) of sterile castor oil in a sterile glass vial under laminar flow, removing a volume (400ul)of oil with micropipette (sterile tips), and replacing this volume with an equal volume of alcoholic CsA solution [200mg cyclosporine in 8 ml ethanol (96%)] under laminar flow.; Placebo
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is prospective randomized comparative clinical study that included 80 eyes of 40 patients with moderate to severe DED. Patients were divided into two groups; group A received topical CsA 0.05% for 3 months, and group B were controls.
Masking: Single (Participant)
Primary purpose: Treatment