Diurnal Variation of Tear Meniscus and Tear Osmolarity

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

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Detailed Description

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This study is to determine the diurnal variation of tear meniscus using OCT and tear osmolarity using Tearlab's osmolarity system in normal subjects and dry eye patients.

Conditions

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Dry Eye

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Normal subjects

No interventions assigned to this group

Dry eye

clinically diagnosed dry eye with aqueous tear deficiency

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas;
5. Has 20/100 uncorrected visual acuity or better;
6. Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
7. Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
8. Has dry eye according to the study definition of DES (study subjects).

Exclusion Criteria

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
3. Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
6. Has worn rigid gas permeable lenses within 1 year;
7. Has had surgery or an eye injury within 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes