Acute Comfort of Lubricant Eye Drops FID 112903

January 31, 2012 updated by: Alcon Research
To evaluate the acute comfort and blurring profile between two 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
      • Mansfield, Texas, United States, 76134
        • Mansfield

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
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye one time
Other: Lubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye 1 time
ACTIVE_COMPARATOR: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye 1 time
Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drop Comfort Upon Instillation
Time Frame: Three minutes
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Three minutes

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

May 1, 2008

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (ESTIMATE)

May 7, 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

  • C-07-17

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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