Diurnal Variation in Tear Osmolarity

Dry Eye Disease Clinical Trial

Official title:

Investigator Sponsored, Pilot Study to Assess the Diurnal Variation in Tear Osmolarity as a Predictor of Dry Eye Disease Etiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321424
• Other study ID #: ALRGN01
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: April 22, 2016
• Start date: March 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Ophthalmic Consultants of Long Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Connecticut	Fairfield	Connecticut
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Ophthalmic Consultants of Long Island	Manhasset	New York
United States	Ophthalmic Consultants of Long Island	Port Jefferson	New York
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Ophthalmic Consultants of Long Island	Valley Stream	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Long Island	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Ocular Improvement	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	31 Days	No