Tear Collection in Adult Volunteers

November 17, 2014 updated by: Allergan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult volunteers without ocular disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
Procedure: Tear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 195263-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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