A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop

May 27, 2011 updated by: Allergan
The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects with dry eye will be evaluated in comparison with currently-available lubricant eye drops.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 2
  • Phase 3

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

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:

  • Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use;
  • Reduced tear stability or tear production

Exclusion Criteria:

  • NONE

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Dry Eye Symptoms

Secondary Outcome Measures

Outcome Measure
Ocular surface damage, tear stability, tear production

Collaborators and Investigators

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

Sponsor

Allergan

Investigators

  • Principal Investigator: Mark Curtis, O.D., InSight Eyecare

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, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 25, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG9689-001

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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Locations

3
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