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Diurnal Variation in Tear Osmolarity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Ophthalmic Consultants of Long Island.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier:
NCT01321424
First received: March 21, 2011
Last updated: November 16, 2012
Last verified: March 2011
History of Changes
  Purpose

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.


Condition
Dry Eye Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Investigator Sponsored, Pilot Study to Assess the Diurnal Variation in Tear Osmolarity as a Predictor of Dry Eye Disease Etiology

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Ophthalmic Consultants of Long Island:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 Day (AM and PM Diurnal) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular Improvement [ Time Frame: 31 Days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aqueous Dificiency Dry Eye
Meibomian Gland Disease Dry Eye
Normal 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care facility

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321424

Contacts
Contact: Joan Fredrickson 516-705-7140 jfredrickson@ocli.net

Locations
United States, Connecticut
Ophthalmic Consultants of Connecticut Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Denise Lavin     203-366-8000     DLavin@occeye.com    
Sub-Investigator: Jonathan Stein, MD            
Sub-Investigator: Joseph J Thimons, OD            
United States, New York
Ophthalmic Consultants of Long Island Recruiting
Lynbrook, New York, United States, 11563
Contact: Diane LaRosa, RN     516-593-4026     dlarosa@ocli.net    
Principal Investigator: Eric D Donnenfeld, MD            
Sub-Investigator: Marguerite B McDonald, MD            
Sub-Investigator: Raymond E Mariani, OD            
Sub-Investigator: Paul R Galstian, OD            
Ophthalmic Consultants of Long Island Recruiting
Manhasset, New York, United States, 11030
Contact: Anne Boubaris     516-627-3232     aboubaris@ocli.net    
Sub-Investigator: Robert D Broderick, MD            
Ophthalmic Consultants of Long Island Recruiting
Port Jefferson, New York, United States, 11777
Contact: Stacey Kruck     631-828-7100     skruck@ocli.net    
Sub-Investigator: John Wittpenn, MD            
Ophthalmic Consultants of Long Island Recruiting
Rockville Centre, New York, United States, 11570
Contact: Joan Fredrickson     516-705-7140     jfredrickson@ocli.net    
Principal Investigator: Eric D Donnenfeld, MD            
Sub-Investigator: Henry D Perry, MD            
Sub-Investigator: Raymond E Mariani, OD            
Sub-Investigator: Marguerite B McDonald, MD            
Sub-Investigator: Allon Barsam, MD            
Ophthalmic Consultants of Long Island Recruiting
Valley Stream, New York, United States, 11581
Contact: Shannon Donoghue     516-374-4199     sdonghue@ocli.net    
Sub-Investigator: Gerard D'Aversa, MD            
Sub-Investigator: Raymond E Mariani, OD            
Sub-Investigator: Paul R Galstian, OD            
Sponsors and Collaborators
Ophthalmic Consultants of Long Island
Allergan
Investigators
Principal Investigator: Eric D Donnenfeld, MD Ophthalmic Consultants of Long Island
Study Director: Barbara Burger, RN Ophthalmic Consultants of Long Island
  More Information

No publications provided

Responsible Party: Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier: NCT01321424     History of Changes
Other Study ID Numbers: ALRGN01
Study First Received: March 21, 2011
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Long Island:
Dry Eye
Tear Osmolarity
Meibomain Gland Disease
Aqueous Dificiency
Tear film abnormality

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 21, 2013