Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

November 17, 2016 updated by: Alcon Research
The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center for Trial Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (minimum age 18) meeting specific criteria for dry eye.

Exclusion Criteria:

  • Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
  • History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Right Eye
ORB Ocular Emulsion or SootheXP
Other: ORB Ocular Emulsion
lubricant eye drop
Other: Left Eye
ORB Ocular Emulsion or SootheXP
Other: SootheXP Emollient (Lubricant) Eye Drops
lubricant eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid layer thickness
Time Frame: Baseline through 120 minutes post instillation
Baseline through 120 minutes post instillation

Collaborators and Investigators

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

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-046

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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