Eye DiseaseNCT00473278
Analysis of Human Tear Proteins in Children
An observational study of Eye Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Disease
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children less than 18 years of age
Who may be able to join
- 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
Who cannot join
- Age greater than or equal to 18 years
- Patients' parents or legal guardians who refuse to sign study consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Human Tear Proteins in Children: A Pilot Study to Describe the Tear Film Proteome of Pediatric Patients Undergoing Ophthalmic Examination.
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.
- Conditions
- Eye Disease
- Keywords
- tear protein
- Medical subject headings
- Eye Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteome of Human Tears
Measured: Single Exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y. Kahook, MD, Principal investigator, Rocky Mountain Lions Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473278
- Sponsor's protocol ID
- 06-1067
- Status last verified
- Jan 2013
- First submitted
- 11 May 2007
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Human Tear Proteins in Children: A Pilot Study to Describe the Tear Film Proteome of Pediatric Patients Undergoing Ophthalmic Examination.
- ClinicalTrials.gov ID
- NCT00473278
- Acronym / sponsor ID
- 06-1067
- Conditions
- Eye Disease
- Keywords
- tear protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children less than 18 years of age
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Patients' parents or legal guardians who refuse to sign study consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proteome of Human Tears
Time frame: Single Exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Y. Kahook, MD principal investigator
Rocky Mountain Lions Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteome of Human Tears (time frame: Single Exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.