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NCT01969162 Clinical Trial

Tear Collection in Adult Volunteers

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01969162
Other study ID # 195263-008
Secondary ID
Status Completed
Phase N/A
First received October 21, 2013
Last updated November 17, 2014
Start date September 2013
Est. completion date November 2013

Study information
Verified date November 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

-Adult volunteers without ocular disease.

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Tear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Day 1 No
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