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

NCT00809003 | Completed

• 1 other identifier: P/269/07/L
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Dry Eye

Keywords

Non dry eyed(normals)

Study Arms (3)

Sjogren's group

Dry eye

Normals

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care

You may qualify if:

• 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).
• Has read, understood and signed an information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has had an ocular examination in the last two years.
• 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)
• Has read, understood and signed an information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has had an ocular examination in the last two years.
• Has read, understood and signed an information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has clear corneas and no active ocular disease.
• Has had an ocular examination in the last two years.

You may not qualify if:

• A person will be excluded from the study if he/she (Sjogren's group):
• Is a contact lens wearer.
• Has any clinically significant belpharitis.
• Has undergone corneal refractive surgery.
• Is aphakic.
• Has any active ocular disease.
• Is using any systemic or topical medications that may affect ocular health.
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
• 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):
• Is a contact lens wearer.
• Has any clinically significant belpharitis.
• Has undergone corneal refractive surgery.
• Is aphakic.
• Has any active ocular disease.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Contact Lens Research, School of Optometry

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Desmond Fonn, MOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 16, 2008
• Study Start: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 16, 2008

Record last verified: 2008-12

Locations

CA (1)