Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye - Tabular View

Tracking Information

First Received Date ^ICMJE

August 8, 2007

Last Updated Date

May 28, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dry eye symptoms as measured by OSDI© [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Dry Eye Symptoms

Change History

Complete list of historical versions of study NCT00514852 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Schirmer Test [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Tear Break-Up Time [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Staining [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Patient Acceptability [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Dry eye signs and patient acceptability

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

Official Title ^ICMJE

Brief Summary

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dry Eye Syndrome

Intervention ^ICMJE

Drug: Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose

Study Arms / Comparison Groups

Experimental: Carboxymethylcellulose and Glycerin based artificial tear
Active Comparator: Carboxymethylcellulose

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

316

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria:

Uncontrolled systemic disease
Use of systemic medications affecting dry eye
Pregnancy or planning a pregnancy
Contact lens wear

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00514852

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

AG9818-002

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP