Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Trial website
https://clinicaltrials.gov/study/NCT01969162
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01969162