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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease, Evaporative Dry Eye Disease

Intervention / Treatment
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* Drug: Restasis
* Drug: Refresh Endura


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 < 10mm; Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT < 5 seconds; Patients submitted to refractive surgery, Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits. Exclusion Criteria: patients with punctual occlusion, active ocular infection or inflammatory disease, history of herpetic keratitis, contact lens use during trial period, patients with glaucoma, any eyelid globe malposition abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Refresh Endura<br>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<br>* Refresh Endura is a topical lubricant produced by Allergan, Inc.<br>* Other names: Castor oil;|
| Experimental: Restasis<br>Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months | Drug: Restasis<br>* Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.<br>* Other names: Cyclosporine 0.05%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface inflammation |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaporative, Aqueous deficient, Dry eye disease