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Tear Osmolarity Over Time With Artificial Tears

Primary Purpose

Dry Eye

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Artificial tears

About this trial

This is an interventional diagnostic trial for Dry Eye focused on measuring Dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Milton M. Hom, OD, FAAO.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Refresh tears

Systane Ultra

Visine

Blink tears

Arm Description

Allergan's Refresh tears artificial tear

Alcon's Systane Ultra artificial tear

Visine artificial tear

AMO's blink tears artificial tear

Outcomes

Primary Outcome Measures

Tear osmolarity

Tear osmolarity measured with TearLab instrument

Secondary Outcome Measures

Full Information

NCT ID

NCT01227226

First Posted

October 21, 2010

Last Updated

February 4, 2011

Sponsor

Hom, Milton M., OD, FAAO

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT01227226

Brief Title

Tear Osmolarity Over Time With Artificial Tears

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2011 (Anticipated)

Study Completion Date

March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hom, Milton M., OD, FAAO

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The effect of artificial tears on tear osmolarity

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Refresh tears

Arm Type

Active Comparator

Arm Description

Allergan's Refresh tears artificial tear

Arm Title

Systane Ultra

Arm Type

Active Comparator

Arm Description

Alcon's Systane Ultra artificial tear

Arm Title

Visine

Arm Type

Active Comparator

Arm Description

Visine artificial tear

Arm Title

Blink tears

Arm Type

Active Comparator

Arm Description

AMO's blink tears artificial tear

Intervention Type

Drug

Intervention Name(s)

Artificial tears

Other Intervention Name(s)

Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears

Intervention Description

Instill one drop of artificial tears

Primary Outcome Measure Information:

Title

Tear osmolarity

Description

Tear osmolarity measured with TearLab instrument

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Milton M Hom, OD FAAO

Organizational Affiliation

Private Practice

Official's Role

Principal Investigator

Facility Information:

Facility Name

Milton M. Hom, OD, FAAO.

City

Azusa

State/Province

California

ZIP/Postal Code

91702

Country

United States

12. IPD Sharing Statement

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Tear Osmolarity Over Time With Artificial Tears

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