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

Phase 4

Completed

• Conditions: Primary Sjogren Syndrome; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Evaporative Dry Eye Disease
• Interventions: Drug: Restasis; Drug: Refresh Endura

• Registration Number: NCT02004067
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restasis	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
Refresh Endura	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.

Primary Outcome Measures

Name	Time	Method
Ocular surface inflammation	3 months

Trial Locations

Locations (1)

Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP; 🇧🇷 Sao Paulo, SP, Brazil