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

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ClinicalTrials.gov Identifier: NCT02004067
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Primary Sjogren Syndrome Secondary Sjogren Syndrome Aqueous Deficient Dry Eye Disease Evaporative Dry Eye Disease Drug: Restasis Drug: Refresh Endura Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Study Start Date : January 2013
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Drug: Refresh Endura
Refresh Endura is a topical lubricant produced by Allergan, Inc.
Other Name: Castor oil
Experimental: 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
Drug: Restasis
Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
Other Name: Cyclosporine 0.05%


Outcome Measures

Primary Outcome Measures :
  1. Ocular surface inflammation [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004067


Locations
Brazil
Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP
Sao Paulo, SP, Brazil, 04023 062
Sponsors and Collaborators
Federal University of São Paulo
Allergan
Investigators
Principal Investigator: Rossen M Hazarbassanov, PhD Federal University of São Paulo
More Information

Responsible Party: Rossen Mihaylov Hazarbassanov, MD, PhD, Researcher, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02004067     History of Changes
Other Study ID Numbers: CAAE: 17821013.0.0000.5505
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo:
Evaporative
Aqueous deficient
Dry eye disease

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Sjogren's Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
Castor Oil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action