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

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

This study has been completed.

Study NCT00514852. Last updated on May 28, 2008. Information provided by Allergan

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Dry Eye Syndrome

Intervention ^†

Drug: Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

316

Start Date ^†

October 2007

Completion Date

January 2008

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00514852

Organization ID

AG9818-002

Secondary IDs ^††

Study Sponsor ^†

Allergan

Collaborators ^††

Investigators ^†

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

May 2008

First Received Date ^†

August 8, 2007

Last Updated Date

May 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.