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Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in 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: NCT01118754
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Tracking Information
First Submitted Date  ICMJE April 29, 2010
First Posted Date  ICMJE May 7, 2010
Last Update Posted Date November 3, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
  • Total fluorescein corneal staining [ Time Frame: 8 weeks ]
  • Ocular Symptom Severity [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
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 Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Official Title  ICMJE Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
Brief Summary The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: DE-101 ophthalmic suspension
    Ophthalmic suspention; QID
  • Drug: DE-101 ophthalmic suspension
    Ophthalmic suspension; QID
  • Drug: DE-101 ophthalmic suspension vehicle
    ophthalmic suspension vehicle; QID
Study Arms  ICMJE
  • Experimental: DE-101 ophthalmic suspension high dose
    Intervention: Drug: DE-101 ophthalmic suspension
  • Experimental: DE-101 ophthalmic suspension low dose
    Interventions:
    • Drug: DE-101 ophthalmic suspension
    • Drug: DE-101 ophthalmic suspension
  • Placebo Comparator: DE-101 ophthalmic suspension vehicle
    Interventions:
    • Drug: DE-101 ophthalmic suspension
    • Drug: DE-101 ophthalmic suspension vehicle
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
Estimated Enrollment  ICMJE
 (submitted: May 5, 2010)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmed diagnosis of dry eye defined by protocol
  • 18 years or older, and sign written informed consent
  • negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion Criteria:

  • use of any topical ocular medications
  • any ocular surgery within 90 days of study
  • laser refractive surgery within one year of study
  • ocular, lid disease/abnormalities that may interfere with the study
  • corneal transplants
  • uncontrolled systemic conditions
  • females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
  • participated in another drug trial within 30 days prior to study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01118754
Other Study ID Numbers  ICMJE 26-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Santen Inc.
Original Responsible Party Naveed Shams, Santen Inc
Current Study Sponsor  ICMJE Santen Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Santen Inc.
Verification Date November 2011

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