Diurnal Variation in Tear Osmolarity

Completed

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT01321424

Run by

Ophthalmic Consultants of Long Island

People needed

60

Starts

2011-03-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females ≥ 18 years old
• Negative urine pregnancy results for females of childbearing potential
• Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures
• Has 20/40 BCVA or better in at least one eye
• Does not currently wear contact lenses
• 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
• 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+
• 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

You may not qualify if…

• Any topical medication within the last three months, except for artificial tears
• Unable to discontinue use of artificial tears during the course of the day for Visit 2
• Any Systemic disease, which in the opinion of the Investigator, may affect ocular health or confound study results
• 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
• Clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
• Clinically significant limbal or bulbar injection, or corneal staining not due to DES
• Has worn hard or rigid gas permeable contact lenses within 1 year
• Has worn soft contact lenses within 1 week
• Has had eye surgery or an eye injury within 6 months
• Positive urine pregnancy results for females of childbearing potential
• 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

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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