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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Start

First participant enrolled

March 1, 2011

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed

Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4.9 years

First QC Date

March 21, 2011

Last Update Submit

April 22, 2016

Conditions

Dry Eye Disease

Keywords

Dry EyeTear OsmolarityMeibomain Gland DiseaseAqueous DificiencyTear film abnormality

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Ocular Improvement
31 Days

Study Arms (3)

Aqueous Dificiency Dry Eye

20 Participants

Meibomian Gland Disease Dry Eye

20 Participants

Normal Eye

20 Participants

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Primary care facility

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
+9 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ophthalmic Consultants of Long Islandlead
Allergancollaborator