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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-08-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Refresh Endura

Intervention Type DRUG

Refresh Endura is a topical lubricant produced by Allergan, Inc.

Restasis

Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months

Group Type EXPERIMENTAL

Restasis

Intervention Type DRUG

Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.

Interventions

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Restasis

Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.

Intervention Type DRUG

Refresh Endura

Refresh Endura is a topical lubricant produced by Allergan, Inc.

Intervention Type DRUG

Other Intervention Names

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Cyclosporine 0.05% Castor oil

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No