Tear Osmolarity Over Time With Artificial Tears

NCT ID: NCT01227226

Last Updated: 2011-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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The effect of artificial tears on tear osmolarity

Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Refresh tears

Allergan's Refresh tears artificial tear

Group Type ACTIVE_COMPARATOR

Artificial tears

Intervention Type DRUG

Instill one drop of artificial tears

Systane Ultra

Alcon's Systane Ultra artificial tear

Group Type ACTIVE_COMPARATOR

Artificial tears

Intervention Type DRUG

Instill one drop of artificial tears

Visine

Visine artificial tear

Group Type ACTIVE_COMPARATOR

Artificial tears

Intervention Type DRUG

Instill one drop of artificial tears

Blink tears

AMO's blink tears artificial tear

Group Type ACTIVE_COMPARATOR

Artificial tears

Intervention Type DRUG

Instill one drop of artificial tears

Interventions

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Artificial tears

Instill one drop of artificial tears

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Hom, Milton M., OD, FAAO

INDIV

Sponsor Role lead

Responsible Party

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Private Practice

Principal Investigators

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Milton M Hom, OD FAAO

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Milton M. Hom, OD, FAAO.

Azusa, California, United States

Site Status

Countries

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United States

Other Identifiers

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06

Identifier Type: -

Identifier Source: org_study_id

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