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

Evaporative Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004067
• Other study ID #: 17821013.0.0000.5505
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aqueous Deficient Dry Eye Disease
• Dry Eye Syndromes
• Evaporative Dry Eye Disease
• Eye Diseases
• Keratoconjunctivitis Sicca
• Primary Sjogren Syndrome
• Secondary Sjogren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Restasis
Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
• Refresh Endura
Refresh Endura is a topical lubricant produced by Allergan, Inc.

Locations

Country	Name	City	State
Brazil	Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Allergan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular surface inflammation		3 months