NCT00522847

Brief Summary

The purpose of this study is to compare various symptoms and signs of dry-eye as well as stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality of life of the sufferer. These are people who are predominantly female and in the older age groups. Determining what characterises a person with dry-eyes is of importance to understanding the disease process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

August 29, 2007

Last Update Submit

February 12, 2009

Conditions

Keywords

Postmenopausalnon dry eye

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • Is Caucasian, and has full legal capacity to volunteer.
  • Is post-menopausal, with menses ceasing more than 12 months ago.
  • 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 clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.

You may not qualify if:

  • Is on hormone replacement therapy (HRT).
  • Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking.
  • Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.
  • Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function.
  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is participating in any other type of clinical or research study.
  • Is a contact lens wearer.
  • Has blepharitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Contact Lens Research, School of Optometry

Waterloo, Ontario, N2L3G1, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Desmond Fonn, M.Optom

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations