Healthy VolunteersNCT01969162
Tear Collection in Adult Volunteers
An observational study of Healthy Volunteers, run by Allergan at 1 site in Australia.
Trial summary
This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tear Sample Collection
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2013to Nov 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult volunteers without ocular disease.
Who may be able to join
- -Adult volunteers without ocular disease.
Who cannot join
- Systemic medications that could affect eye health taken within 1 month of enrollment
- Eye infection or inflammation in either eye 3 months prior to screening
- History of herpes in either eye
- Diagnosis of dry eye or meibomian gland dysfunction
- Diagnosis of glaucoma
- Allergic conjunctivitis
- Use of rigid contact lenses within 1 year of screening
- Use of soft contact lenses within 1 week of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.
- Conditions
- Healthy Volunteers
- Being tested
- Tear Sample Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear Sample CollectionProcedure or surgery
Tear sample collection as per protocol. No investigational drug is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. Receives: Procedure: Tear Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Lipid Composition Profile
Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969162
- Sponsor's protocol ID
- 195263-008
- Status last verified
- Nov 2014
- First submitted
- 21 Oct 2013
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Collection in Adult Volunteers
- ClinicalTrials.gov ID
- NCT01969162
- Acronym / sponsor ID
- 195263-008
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Procedure: Tear Sample CollectionAdult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult volunteers without ocular disease.
Key inclusion criteria (1 listed)
- -Adult volunteers without ocular disease.
Key exclusion criteria (8 listed)
- Systemic medications that could affect eye health taken within 1 month of enrollment
- Eye infection or inflammation in either eye 3 months prior to screening
- History of herpes in either eye
- Diagnosis of dry eye or meibomian gland dysfunction
- Diagnosis of glaucoma
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 |
|---|---|---|
| Tear Sample CollectionTear sample collection as per protocol. No investigational drug is administered in this study. | Procedure or surgery | All Participants |
Primary outcome
Tear Lipid Composition Profile
Time frame: Day 1
Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
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 Healthy Volunteers, run by Allergan at 1 site in Australia.
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 8 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 21 Nov 2014. 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 Australia. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tear Lipid Composition Profile (time frame: Day 1). 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 21 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.