Tear Osmolarity Over Time With Artificial Tears | NCT01227226

Studies
Tear Osmolarity Over Time With Artificial Tears

NCT01227226

Sponsor

Hom, Milton M., OD, FAAO

Status

Unknown status

Last Update Posted

Feb 7, 2011Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Dry Eye

Interventions

Artificial tears

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Oct 21, 2010

First Submission Date that Met QC Criteria

Oct 22, 2010

First Posted Date

Oct 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2011

Last Update Posted Date

Feb 7, 2011Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Refresh tears	Active Comparator	Allergan's Refresh tears artificial tear	Drug: Artificial tears
Systane Ultra	Active Comparator	Alcon's Systane Ultra artificial tear	Drug: Artificial tears
Visine	Active Comparator	Visine artificial tear	Drug: Artificial tears
Blink tears	Active Comparator	AMO's blink tears artificial tear	Drug: Artificial tears

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artificial tears	Drug	Instill one drop of artificial tears	Blink tears Refresh tears Systane Ultra Visine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milton M Hom, OD FAAO	Private Practice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton M. Hom, OD, FAAO.		Azusa	California	91702	United States

ID	Term
D015352	Dry Eye Syndromes

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D065346	Lubricant Eye Drops

Ancestor Terms

ID	Term
D009883	Ophthalmic Solutions
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided