Tear Osmolarity Over Time With Artificial Tears

February 4, 2011 updated by: Hom, Milton M., OD, FAAO
The effect of artificial tears on tear osmolarity

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Azusa, California, United States, 91702
        • Milton M. Hom, OD, FAAO.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Refresh tears
Allergan's Refresh tears artificial tear
Drug: Artificial tears
Instill one drop of artificial tears
Other Names:
  • Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Systane Ultra
Alcon's Systane Ultra artificial tear
Drug: Artificial tears
Instill one drop of artificial tears
Other Names:
  • Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Visine
Visine artificial tear
Drug: Artificial tears
Instill one drop of artificial tears
Other Names:
  • Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Active Comparator: Blink tears
AMO's blink tears artificial tear
Drug: Artificial tears
Instill one drop of artificial tears
Other Names:
  • Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear osmolarity
Time Frame: 2 days
Tear osmolarity measured with TearLab instrument
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hom, Milton M., OD, FAAO

Collaborators

Allergan

Investigators

  • Principal Investigator: Milton M Hom, OD FAAO, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 7, 2011

Last Update Submitted That Met QC Criteria

February 4, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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