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

NCT ID: NCT00809003

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sjogren's Syndrome Dry Eye

Keywords

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Non dry eyed(normals)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sjogren's group

No interventions assigned to this group

Dry eye

No interventions assigned to this group

Normals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.


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.


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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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CCLR

Principal Investigators

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Desmond Fonn, MOptom

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

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Centre for Contact Lens Research, School of Optometry

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P/269/07/L

Identifier Type: -

Identifier Source: org_study_id