NCT00473278

Brief Summary

The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film, and any unique aspects of tears in children. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

May 11, 2007

Last Update Submit

January 29, 2013

Conditions

Eye Disease

Keywords

tear protein

Outcome Measures

Primary Outcomes (1)

  • Proteome of Human Tears

    Single Exam

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children less than 18 years of age

You may qualify if:

  • Less than 18 years of age
  • A parent or legal guardian provide written informed consent to participate
  • Able to cooperate with tear sample collection, or a previously planned sedation for other medical purposes

You may not qualify if:

  • Age greater than or equal to 18 years
  • Patients' parents or legal guardians who refuse to sign study consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Childrens Hospital

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Malik Y. Kahook, MD

    Rocky Mountain Lions Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2007

First Posted

May 15, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

US(1)