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

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Evaporative Dry Eye Disease; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Primary Sjogren Syndrome

Treatments: Drug: Refresh Endura; Drug: Restasis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02004067

17821013.0.0000.5505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Refresh Endura

Active Comparator group

Description:

Topical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months.

Treatment:

Drug: Refresh Endura

Restasis

Experimental group

Description:

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

Treatment:

Drug: Restasis