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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00809003
First received: December 12, 2008
Last updated: December 15, 2008
Last verified: December 2008
  Purpose

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
Sjogren's Syndrome
Dry Eye

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: December 2007
Groups/Cohorts
Sjogren's group
Dry eye
Normals

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.

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care

Criteria

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
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: NCT00809003

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Dr Craig Woods, CCLR
ClinicalTrials.gov Identifier: NCT00809003     History of Changes
Other Study ID Numbers: P/269/07/L
Study First Received: December 12, 2008
Last Updated: December 15, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Waterloo:
Non dry eyed(normals)

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Sjogren's Syndrome
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

ClinicalTrials.gov processed this record on October 19, 2014