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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Federal University of São Paulo
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02004067
First received: December 3, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Primary Sjogren Syndrome
Secondary Sjogren Syndrome
Aqueous Deficient Dry Eye Disease
Evaporative Dry Eye Disease
Drug: Restasis
Drug: Refresh Endura
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Ocular surface inflammation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004067

Contacts
Contact: Rossen M Hazarbassanov, PhD +551150852031 hazarbassanov@gmail.com

Locations
Brazil
Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP Recruiting
Sao Paulo, SP, Brazil, 04023 062
Contact: Rossen M Hazarbassanov, PhD    +551150852031      
Principal Investigator: Rossen M Hazarbassanov, MD, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Allergan
Investigators
Principal Investigator: Rossen M Hazarbassanov, PhD Federal University of São Paulo
  More Information

No publications provided

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
Study First Received: December 3, 2013
Last Updated: June 2, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Evaporative
Aqueous deficient
Dry eye disease

Additional relevant MeSH terms:
Sjogren's Syndrome
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Syndrome
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Conjunctival Diseases
Conjunctivitis
Connective Tissue Diseases
Corneal Diseases
Disease
Immune System Diseases
Joint Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Xerostomia
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 22, 2014