Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Artificial Tears Study in Mild to Moderate Dry Eye Patients
This study has been completed.
Sponsored by: Advanced Medical Optics
Information provided by: Advanced Medical Optics
ClinicalTrials.gov Identifier: NCT00607776
  Purpose

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.


Condition Intervention Phase
Dry Eye
Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drug: Systane
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Artificial Tears Study in Mild to Moderate Dry Eye Patients

Further study details as provided by Advanced Medical Optics:

Primary Outcome Measures:
  • Subjective ocular comfort [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vision quality [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2007
Study Completion Date: April 2007
Arms Assigned Interventions
1: Active Comparator
Systane
Drug: Systane
Drops
2: Experimental
Blink tears
Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to moderate dry eye
  • over 18

Exclusion Criteria:

  • No concurrent ocular disease or meds
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607776

Sponsors and Collaborators
Advanced Medical Optics
Investigators
Principal Investigator: Eric Donnenfeld, M.D. Ophthalmic Consultants of Long Island
  More Information

Responsible Party: AMO, Inc. ( Lynn Lasswell, O.D., Director, Eye Care Clinical Research )
Study ID Numbers: PEGT-104-9582
Study First Received: December 19, 2007
Last Updated: February 5, 2008
ClinicalTrials.gov Identifier: NCT00607776  
Health Authority: United States: Institutional Review Board

Keywords provided by Advanced Medical Optics:
dry, eyes
Amelioration of dry eye symptoms

Study placed in the following topic categories:
Lacerations

ClinicalTrials.gov processed this record on January 16, 2009