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JADE: Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease

Sponsor
University of Waterloo (Other)
Overall Status
Completed
CT.gov ID
NCT00809003
Collaborator
Alcon Research (Industry)
60
Enrollment
1
Location
3
Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project will examine the similarities and differences of the ocular surface and tear film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do not have dry eye. This knowledge will help clinicians understand the processes that create these dry eye conditions and will strengthen the treatment and management strategies that will be used. The subjects will participate in a series of dry eye tests that they have already experienced in clinic, along with the gathering of tear samples and surface cells. These tissues will then be analyzed at a distant site.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Dry eye 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. A number of factors have been implicated in triggering this disease, including age, hormone changes and autoimmune disease.

    Sjogren's syndrome(SS) is a common autoimmune disorder, characterized by chronic inflammatory infiltration of exocrine glands (particularly salivary and lacrimal) and systemic immune reactivity, resulting in dry eye and dry mouth. The mechanism of inflammation of the lacrimal gland in these patients is well documented. It is believed that these pathological changes facilitate the secretion of inflammatory biochemicals on to the ocular surface. Additionally, in SS, there are also pathological changes to epithelial cells of the cornea and conjunctiva (such as upregulation of mRNAs coding for inflammatory cytokines) which subsequently contribute to the increased secretion of the cytokines themselves. Taken together, these changes result in an increased concentration of inflammatory mediators in the tear film, which then drive the propagation of the dry eye disease process. Severe dry eye (DE) patients present with a very similar clinical outcome to SS patients, however, inflammatory processes associated with either the initiation or propagation of their dry eye disease has not been well characterized.

    This research project was established to quantify similarities and / or differences between SS and severe dry eye participants, with respect to ocular surface inflammation and function. Specifically, this study will examine dry eye symptoms, ocular surface integrity and tear film volume and flow. Additionally, the concentration of inflammatory cytokines present in the tear film will be quantified.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
    Study Start Date :
    Sep 1, 2007
    Actual Study Completion Date :
    Dec 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    Sjogren's group
    Dry eye
    Normals

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      17 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      Inclusion criteria (Sjogren's group)

      A person is eligible for inclusion in the study, for the dry eye group, if she:

      1. Has been diagnosed to have SS(confirmed via American-European Consensus Criteria 2002)and dry eye and half of the time wants to use eye drops for dry eye symptoms (dry eye group).

      2. Has read, understood and signed an information consent letter.

      3. Is willing and able to follow instructions and maintain the appointment schedule.

      4. Has had an ocular examination in the last two years.

      Inclusion criteria (severe DE group)

      A person is eligible for inclusion in the study, for the dry eye group, if he/she:

      1. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group)

      2. Has read, understood and signed an information consent letter.

      3. Is willing and able to follow instructions and maintain the appointment schedule.

      4. Has had an ocular examination in the last two years.

      Inclusion criteria (control group)

      A person is eligible for inclusion in the study, for the control group, if he/she:

      1. Has read, understood and signed an information consent letter.

      2. Is willing and able to follow instructions and maintain the appointment schedule.

      3. Has clear corneas and no active ocular disease.

      4. Has had an ocular examination in the last two years.

      Exclusion Criteria:
      A person will be excluded from the study if he/she (Sjogren's group):

      1. Is a contact lens wearer.

      2. Has any clinically significant belpharitis.

      3. Has undergone corneal refractive surgery.

      4. Is aphakic.

      5. Has any active ocular disease.

      6. Is using any systemic or topical medications that may affect ocular health.

      7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

      8. Is participating in any other type of clinical or research study.

      A person will be excluded from the study if he/she (Dry eye group):

      1. Is a contact lens wearer.

      2. Has any clinically significant belpharitis.

      3. Has undergone corneal refractive surgery.

      4. Is aphakic.

      5. Has any active ocular disease.

      6. Is using any systemic or topical medications that may affect ocular health.

      7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

      8. Is participating in any other type of clinical or research study.

      A person will be excluded from the study if he/she (control group):

      1. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.

      2. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuro-endocrine system function.

      3. Has undergone corneal refractive surgery.

      4. Is aphakic.

      5. Has any active ocular disease.

      6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

      7. Is participating in any other type of clinical or research study.

      8. Is a contact lens wearer.

      9. Has blepharitis.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Centre for Contact Lens Research, School of Optometry Waterloo Ontario Canada N2L3G1

      Sponsors and Collaborators

      • University of Waterloo
      • Alcon Research

      Investigators

      • Principal Investigator: Desmond Fonn, MOptom, University of Waterloo

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00809003
      Other Study ID Numbers:
      • P/269/07/L
      First Posted:
      Dec 16, 2008
      Last Update Posted:
      Dec 16, 2008
      Last Verified:
      Dec 1, 2008
      Keywords provided by , ,
      Non dry eyed(normals)
      Additional relevant MeSH terms:
      Sjogren's Syndrome
      Dry Eye Syndromes
      Keratoconjunctivitis Sicca
      Eye Diseases

      Study Results

      No Results Posted as of Dec 16, 2008