Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops

January 31, 2012 updated by: Alcon Research
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

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:

  • documented diagnosis of dry eye

Exclusion Criteria:

  • use of topical ocular drops within 2 hours preceding 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each one time
Other: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops one drop each eye one time
Active Comparator: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye one time
Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops one drop each eye one time
Active Comparator: Blink Tears
Blink Tears 1 drop each eye one time
Other: Blink Tears
Blink Tears one drop each eye one time
Active Comparator: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time
Other: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops one drop each eye one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drop Comfort
Time Frame: once upon instillation
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.
once upon instillation

Collaborators and Investigators

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

Sponsor

Alcon Research

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, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-08-10

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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