Study Results
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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COMPLETED
40 participants
OBSERVATIONAL
2009-11-30
2010-10-31
Brief Summary
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The patients classified as having dry eye will also have their tear film thickness measured after instillation of an artificial tear. This will potentially reveal valuable data in retention of effect measured non-invasively as in prior studies that employed a fluorescein tracer.
Detailed Description
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Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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Normal (non-dry) dry eye subjects
These are healthy individuals, age 18 and above, who do not exhibit dry eyes by signs and symptoms
No interventions assigned to this group
Dry eye subjects
These are subjects, age 18 years and above, who do exhibit signs and symptoms of dry eye.
No interventions assigned to this group
Eligibility Criteria
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Exclusion Criteria
2. Adult subjects, 18 years of age and older. Criteria for the mild to severe dry eye group must include two of the three following characteristics as demonstrated at the Eligibility visit:
1. Composite symptom score of ≥ 7 on the Schein questionnaire:
2. Sodium fluorescein (NaFl) tear break-up time ≤ 7 seconds in either (worse) eye
3. Cumulative sodium fluorescein (NaFl) corneal staining ≥ 4 in either (worse) eye on a 0-20 point scale (corresponds to ≥ 3.0 on a 0-15 scale).
3. Able and willing to follow study instructions.
4. Willing to return for the repeatability visit within 7 plus or minus 2 days of the initial visit, and within the same one-half day (i.e., either in the morning or afternoon, similar to the first tear thickness visit).
5. Subjects must have best corrected visual acuity of 20/25 or better in each eye as assessed using a standard Snellen acuity chart.
6. Subjects wearing soft contacts lenses must be willing to discontinue wear for two days before each study visit.
7. Subjects using any topical drops such as artificial tears must be willing to discontinue use of such drops for two days prior to all visits, including the baseline visit.
Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study:
1. History or evidence of ocular or intraocular surgery in either eye within the past six months. LASIK and other kerato-refractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more months prior.
2. History or evidence of serious ocular trauma in either eye within the past six months.
3. History of hypersensitivity to sodium fluorescein.
4. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
5. Patients requiring use of topical ocular medications such as glaucoma or allergy medications during the study period.
6. Individuals using systemic steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the first visit. In addition, the dosing regimen must remain stable throughout the study period, expected to be approximately one week.
7. Individuals with diabetes.
8. Ocular conditions such as conjunctival infections, or iritis.
9. Individuals wearing rigid gas permeable contact lenses or using punctal plugs.
10. Participation in an investigational drug or device study within 30 days of entering this study.
18 Years
ALL
Yes
Sponsors
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Southern California College of Optometry at Marshall B. Ketchum University
OTHER
Responsible Party
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Southern California College of Optometry
Principal Investigators
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Jerry Paugh, OD. PhD
Role: STUDY_DIRECTOR
Southern California College of Optometry at Marshall B. Ketchum University
Locations
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Southern California College of Optometry
Fullerton, California, United States
Countries
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Other Identifiers
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09-10
Identifier Type: -
Identifier Source: org_study_id