Clinical trial NCT01321424: Diurnal Variation in Tear Osmolarity
Official title: Investigator Sponsored, Pilot Study to Assess the Diurnal Variation in Tear Osmolarity as a Predictor of Dry Eye Disease Etiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Keywords: Dry Eye
Tear Osmolarity
Meibomain Gland Disease
Aqueous Dificiency
Tear film abnormality
Lead sponsor: Ophthalmic Consultants of Long Island
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care facility

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 Day (AM and PM Diurnal)
Secondary outcomes:
measure: Ocular Improvement
timeFrame: 31 Days
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Manhasset
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Port Jefferson
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Valley Stream
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric D Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Long Island
name: Barbara Burger, RN
role: STUDY_DIRECTOR
References: