NCT02004067

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Sjogren Syndrome
• Secondary Sjogren Syndrome
• Aqueous Deficient Dry Eye Disease
• Evaporative Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Restasis	Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
DRUG	Refresh Endura	Refresh Endura is a topical lubricant produced by Allergan, Inc.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-12-06
• Last updated: 2020-09-22

Locations

1 site across 1 country: Brazil