Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Ocular surface inflammation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Refresh Endura (Drug)
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
Intervention: Restasis (Drug)
Outcomes
Primary Outcomes
Ocular surface inflammation
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Rossen Mihaylov Hazarbassanov, MD, PhD
Researcher
Federal University of São Paulo