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A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye

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: NCT00399230
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : August 21, 2007
Sponsor:
Information provided by:
Innovative Medical

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE November 14, 2006
Last Update Posted Date August 21, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye
Official Title  ICMJE Not Provided
Brief Summary To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Dry Eye
Intervention  ICMJE Drug: Optive
Study Arms  ICMJE Not Provided
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 Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • · Dry eye disease diagnosis

    • Patients must currently be using Systane tears at least once a day and for at least 1 month.
    • Normal lid position and closure
    • Male or female of legal age of consent
    • Informed consent has been obtained
    • Likely to complete all required follow-up visits

Exclusion Criteria:

  • · Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study.

    • Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00399230
Other Study ID Numbers  ICMJE 5279
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Innovative Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajesh Rajpal, MD See Clearly Vision Group
PRS Account Innovative Medical
Verification Date August 2007

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