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NCT01227226 Clinical Trial

Tear Osmolarity Over Time With Artificial Tears

Dry Eye Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01227226
Other study ID # 06
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received October 21, 2010
Last updated February 4, 2011
Start date October 2010
Est. completion date March 2011

Study information
Verified date February 2011
Source Hom, Milton M., OD, FAAO
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The effect of artificial tears on tear osmolarity

Description:

Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 48
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Artificial tears
Instill one drop of artificial tears

Locations
Country Name City State
United States Milton M. Hom, OD, FAAO. Azusa California

Sponsors (2)
Lead Sponsor Collaborator
Hom, Milton M., OD, FAAO Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tear osmolarity Tear osmolarity measured with TearLab instrument 2 days No
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