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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02004067
Enrollment
100
Registered
2013-12-06
Start date
2013-01-31
Completion date
2016-08-31
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease, Evaporative Dry Eye Disease

Keywords

Evaporative, Aqueous deficient, Dry eye disease

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.

Interventions

Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.

DRUGRefresh Endura

Refresh Endura is a topical lubricant produced by Allergan, Inc.

Sponsors

Allergan
CollaboratorINDUSTRY
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frame
Ocular surface inflammation3 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026