Pilot Study of Human Tear Proteins | NCT00453258

Studies
Pilot Study of Human Tear Proteins

NCT00453258

Sponsor

University of Colorado, Denver

Status

Terminated

Last Update Posted

Jan 17, 2013Estimated

Enrollment

63Actual

Phase

Not provided

Conditions

Eye Disease

Interventions

Eye Examination

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

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped due to low enrollment

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Mar 26, 2007

First Submission Date that Met QC Criteria

Mar 27, 2007

First Posted Date

Mar 28, 2007Estimated

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

Jan 15, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film from diseased and non-diseased patients. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Subject		Subjects receiving eye examination	Other: Eye Examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eye Examination	Other	Subjects receiving eye examination	Study Subject

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plan Prospective Research	Pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.	Throughout study participation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
able to cooperate with tear sample collection
provide written informed consent

Exclusion Criteria:

special populations (children, pregnant or lactating females, prisoners, etc)
refusal to sign sudy consent

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

Subjects receiving eye examination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malik Y. Kahook, MD	Rocky Mountain Lions Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rocky Mountain Lions Eye Institute		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided