Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
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.
Primary Sjogren Syndrome
Secondary Sjogren Syndrome
Aqueous Deficient Dry Eye Disease
Evaporative Dry Eye Disease
Drug: Refresh Endura
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease|
- Ocular surface inflammation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Refresh Endura
Topical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months.
Drug: Refresh Endura
Refresh Endura is a topical lubricant produced by Allergan, Inc.
Other Name: Castor oil
Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months
Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
Other Name: Cyclosporine 0.05%
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004067
|Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP|
|Sao Paulo, SP, Brazil, 04023 062|
|Principal Investigator:||Rossen M Hazarbassanov, PhD||Federal University of São Paulo|