Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Artificial Tears Study in Mild to Moderate Dry Eye Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607776
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 6, 2008
Sponsor:
Information provided by:
Abbott Medical Optics

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date February 6, 2008
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Subjective ocular comfort [ Time Frame: 1 Month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Vision quality [ Time Frame: 1 Month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: February 5, 2008)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607776
Other Study ID Numbers  ICMJE PEGT-104-9582
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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