Diurnal Variation in Tear Osmolarity

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Ophthalmic Consultants of Connecticut
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Manhasset, New York, United States, 11030
      • Ophthalmic Consultants of Long Island
    • Port Jefferson, New York, United States, 11777
      • Ophthalmic Consultants of Long Island
    • Rockville Centre, New York, United States, 11570
      • Ophthalmic Consultants of Long Island
    • Valley Stream, New York, United States, 11581
      • Ophthalmic Consultants of Long Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care facility

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Aqueous Dificiency Dry Eye; 20 Participants
Meibomian Gland Disease Dry Eye; 20 Participants
Normal Eye; 20 Participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of Long Island
• Collaborators: Allergan
• Investigators: Principal Investigator: Eric D Donnenfeld, MD, Ophthalmic Consultants of Long Island; Study Director: Barbara Burger, RN, Ophthalmic Consultants of Long Island

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Dry Eye; Tear Osmolarity; Meibomain Gland Disease; Aqueous Dificiency; Tear film abnormality
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: ALRGN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: PI will present study outcomes to associates