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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01969162




Registration number
NCT01969162
Ethics application status
Date submitted
21/10/2013
Date registered
25/10/2013
Date last updated
21/11/2014

Titles & IDs
Public title
Tear Collection in Adult Volunteers
Scientific title
Secondary ID [1] 0 0
195263-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Tear Sample Collection

All Participants - Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.


Treatment: Surgery: Tear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tear Lipid Composition Profile
Timepoint [1] 0 0
Day 1

Eligibility
Key inclusion criteria
-Adult volunteers without ocular disease.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01969162