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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00399230
First received: November 9, 2006
Last updated: August 17, 2007
Last verified: August 2007
History of Changes
  Purpose

To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.


Condition Intervention Phase
Dry Eye
 Drug: Optive
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Innovative Medical:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399230

Locations
United States, Virginia
Dr. Rajpal
McLean, Virginia, United States, 22102
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Rajesh Rajpal, MD See Clearly Vision Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399230     History of Changes
Other Study ID Numbers: 5279
Study First Received: November 9, 2006
Last Updated: August 17, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 23, 2013