Clinical trial NCT02004067: Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Official title: Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Sjogren Syndrome
Secondary Sjogren Syndrome
Aqueous Deficient Dry Eye Disease
Evaporative Dry Eye Disease
Keywords: Evaporative
Aqueous deficient
Dry eye disease
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ocular surface inflammation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Rossen M Hazarbassanov, PhD
role: PRINCIPAL_INVESTIGATOR
References: