Diurnal Variation in Tear Osmolarity

Completed

• Conditions: Dry Eye Disease

• Registration Number: NCT01321424
• Lead Sponsor: Ophthalmic Consultants of Long Island

Brief Summary

The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.

Detailed Description

The premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Healthy males and females ≥ 18 years old

2. Negative urine pregnancy results for females of childbearing potential

3. Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures

4. Has 20/40 BCVA or better in at least one eye

5. Does not currently wear contact lenses

6. For Aqueous-Deficiency Group:

   • Has symptoms of Dry Eye
   • Schirmer testing ≤ 10 mm
   • Tear Break Up Time ≤ 8 seconds
   • Conjunctival staining ≥ 1+
   • Meibomian gland inspissations ≤ 1+
   • No lid thickening, lid erythema, or thickened, turbid meibomian gland secretions

7. For Meibomian Gland Disease Group:

   • Has symptoms of Dry Eye
   • Schirmer testing ≥ 10 mm
   • Tear Break Up Time ≤ 8 seconds
   • Conjunctival staining ≥ 1+
   • Meibomian gland inspissations ≥ 2+

8. For Normal Group:

   • Has no symptoms of Dry Eye
   • Schirmer testing > 10 mm
   • Tear Break Up Time > 8 seconds
   • No or trace Conjunctival staining
   • No Meibomian gland inspissations

Exclusion Criteria

1. Any topical medication within the last three months, except for artificial tears
2. Unable to discontinue use of artificial tears during the course of the day for Visit 2
3. Any Systemic disease, which in the opinion of the Investigator, may affect ocular health or confound study results
4. Any active ocular disease other than Dry Eye Disease, Meibomian Gland Disease or Sjogren's Syndrome, which in the opinion of the Investigator, may affect ocular health or confound study results
5. Clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
6. Clinically significant limbal or bulbar injection, or corneal staining not due to DES
7. Has worn hard or rigid gas permeable contact lenses within 1 year
8. Has worn soft contact lenses within 1 week
9. Has had eye surgery or an eye injury within 6 months
10. Positive urine pregnancy results for females of childbearing potential
11. Any changes in current medication within 30 days of Visit 2 or anticipated change during course of study, which in the opinion of the Investigator may confound study results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The measured difference in Tear Osmolarity during the course of the day to support clinical diagnosis and differentiate between aqueous-deficiency and meibomian gland disease.	1 Day (AM and PM Diurnal)

Secondary Outcome Measures

Name	Time	Method
Ocular Improvement	31 Days	Improvement in Ocular Surface Disease Index, Best Corrected Visual Acuity, Uncorrected Visual Acuity, Slit Lamp Exam, Schirmer test, Lissamine green conjunctival staining, Fluorescein corneal staining and Tear Break Up Time

Trial Locations

Locations (2)

Ophthalmic Consultants of Long Island; 🇺🇸 Valley Stream, New York, United States

Ophthalmic Consultants of Connecticut; 🇺🇸 Fairfield, Connecticut, United States