Artificial Tears Study in Mild to Moderate Dry Eye Patients

This study has been completed.

Sponsor:

Information provided by:

Abbott Medical Optics

ClinicalTrials.gov Identifier:

NCT00607776

First received: December 19, 2007

Last updated: February 5, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

February 5, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Subjective ocular comfort [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Vision quality [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Artificial Tears Study in Mild to Moderate Dry Eye Patients

Official Title ^ICMJE

Artificial Tears Study in Mild to Moderate Dry Eye Patients

Brief Summary

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye

Intervention ^ICMJE

Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drops
Drug: Systane
Drops

Study Arm (s)

Active Comparator: 1
Systane

Intervention: Drug: Systane
Experimental: 2
Blink tears

Intervention: Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mild to moderate dry eye
over 18

Exclusion Criteria:

No concurrent ocular disease or meds

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00607776

Other Study ID Numbers ^ICMJE

PEGT-104-9582

Has Data Monitoring Committee

Yes

Responsible Party

Lynn Lasswell, O.D., Director, Eye Care Clinical Research, AMO, Inc.

Study Sponsor ^ICMJE

Abbott Medical Optics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric Donnenfeld, M.D.

Ophthalmic Consultants of Long Island

Information Provided By

Abbott Medical Optics

Verification Date

January 2008

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

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