Normal Healthy EyesNCT00643942
Staining in a Healthy, Non-Dry Eye Population
An observational study of Normal Healthy Eyes, run by Alcon Research at 1 site in United States.
Trial summary
The clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Eyes
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2008
- 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: Patients with normal healthy eyes
Who may be able to join
- Healthy eyes
Who cannot join
- Age related
Trial locations and contacts
1 site in 1 country.
About this study
The clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered.
- Conditions
- Normal Healthy Eyes
- Being tested
- No intervention required
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention requiredOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: No intervention required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy EyesStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643942
- Sponsor's protocol ID
- C-06-23
- Status last verified
- Mar 2008
- First submitted
- 24 Mar 2008
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staining in a Healthy, Non-Dry Eye Population
- ClinicalTrials.gov ID
- NCT00643942
- Acronym / sponsor ID
- C-06-23
- Conditions
- Normal Healthy Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 26 Mar 2008 (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 clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No intervention required |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with normal healthy eyes
Key inclusion criteria (1 listed)
- Healthy eyes
Key exclusion criteria (1 listed)
- Age related
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 |
|---|---|---|
| No intervention required | Other | 1 |
Primary outcome
Corneal fluorescein staining scores
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 12 May 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normal Healthy Eyes, run by Alcon Research 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 1 inclusion and 1 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 12 May 2015. 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?
Corneal fluorescein staining scores. 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 12 May 2015.