Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

January 31, 2012 updated by: Alcon Research
The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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:

  • Must not have worn contact lenses within 12 hours preceding enrollment
  • Must not have used any topical ocular drops or ointment within 24 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lubricant eye drop
Other: Lubricant eye drop FID 115958D
1 drop in each eye, one time
Active Comparator: Refresh PM Ointment
Other: Refresh PM Ointment
1 drop in each eye, one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Three-minute visual blur profile
Time Frame: Through 3 minutes (post-instillation)
Through 3 minutes (post-instillation)
Overall Acceptability
Time Frame: Immediately upon instillation
Immediately upon instillation

Secondary Outcome Measures

Outcome Measure
Time Frame
Drop Comfort Upon Instillation
Time Frame: Immediately upon installation
Immediately upon installation

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

January 1, 2010

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

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-09-059

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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