Safety/Efficacy of Systane Free vs Refresh Liquigel

March 2, 2012 updated by: Alcon Research

An Evaluation of the Safety and Efficacy of Systane Free FID 105783

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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:

  • >/= 3 corneal staining score using NEI scoring system.
  • Need artificial tears at least some of the time.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medication.
  • Use of Restasis within 30 days of Visit 1.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • Other protocol-defined exclusion criteria may apply.

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
Experimental: Systane
Other: Systane Free Lubricant Eye Drops
1-2 drops per eye four times per day for 42 days
Active Comparator: Refresh
Other: Refresh Liquigel Lubricant Eye Drops
1-2 drops per eye four times per day for 42 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in corneal staining at Day 28 from baseline (Day 0)
Time Frame: Day 28
Day 28

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

July 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-05-45

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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