Eye DiseaseNCT00453258
Pilot Study of Human Tear Proteins
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 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Disease
- What is being tested?
- Eye Examination
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Sep 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects receiving eye examination
Who may be able to join
- 18 years of age and older
- able to cooperate with tear sample collection
- provide written informed consent
Who cannot join
- special populations (children, pregnant or lactating females, prisoners, etc)
- refusal to sign sudy consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045
About this study
Official title: Analysis of Human Tear Proteins: A Pilot Study to Describe the Tear Film Proteome of 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 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.
- Conditions
- Eye Disease
- Being tested
- Eye Examination
- Keywords
- ocular proteomics, eye disease, proteomics
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye ExaminationOther
Subjects receiving eye examination
| Study group | Role | What they receive |
|---|---|---|
| Study Subject | Subjects receiving eye examination Receives: Other: Eye Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Stopped due to low enrollment
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
- 63 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
- NCT00453258
- Sponsor's protocol ID
- 06-0862
- Status last verified
- Oct 2012
- First submitted
- 26 Mar 2007
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Human Tear Proteins: A Pilot Study to Describe the Tear Film Proteome of Patients Undergoing Ophthalmic Examination.
- ClinicalTrials.gov ID
- NCT00453258
- Acronym / sponsor ID
- 06-0862
- Conditions
- Eye Disease
- Keywords
- ocular proteomics, eye disease, proteomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped due to low enrollment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subject | – | Other: Eye ExaminationSubjects receiving eye examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving eye examination
Key inclusion criteria (3 listed)
- 18 years of age and older
- able to cooperate with tear sample collection
- provide written informed consent
Key exclusion criteria (2 listed)
- special populations (children, pregnant or lactating females, prisoners, etc)
- refusal to sign sudy consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye ExaminationSubjects receiving eye examination | Other | Study Subject |
Primary outcome
Plan Prospective Research
Time frame: Throughout study participation
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.
Results and safety
The study was stopped early (reason given: Stopped due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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: stopped early, as of the sponsor's last update on 17 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 was stopped early (reason given: Stopped due to low enrollment). Results are not available in the source record.
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?
Plan Prospective Research (time frame: Throughout study participation). 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 17 Jan 2013.