Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

Evaporative Dry Eye Disease Clinical Trial

Official title: Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

Status Completed

Clinical Trial Summary

In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

Clinical Trial Description

Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. DED prevalence is estimated around 15 -35% of the population over 50 years old. There is a wide variety of topic medications for the treatment of DED, though few aim the re-establishment of tear osmolarity equilibrium and reduction of damages to the ocular surface. The treatment of DED can include a medical treatment, such as tear substitution, tear preservation, production stimulation, anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland transplant. Considering tear substitutes and anti-inflammatory topical treatments, the purpose of our study is to determine efficacy of an immunomodulating topical medication containing 0.05% cyclosporine A (CsA), compared to a topical lubricant (vitamin A, Refresh Endura®), on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED. ;

Related Conditions & MeSH terms

• Aqueous Deficient Dry Eye Disease
• Dry Eye Syndromes
• Evaporative Dry Eye Disease
• Eye Diseases
• Keratoconjunctivitis Sicca
• Primary Sjogren Syndrome
• Secondary Sjogren Syndrome
• Sjogren's Syndrome
• Syndrome

• NCT number: NCT02004067
• Study type: Interventional
• Source: Federal University of São Paulo
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Completion date: August 2016