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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: DE-101 ophthalmic suspension Drug: DE-101 ophthalmic suspension vehicle Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: DE-101 ophthalmic suspension high dose Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID
Experimental: DE-101 ophthalmic suspension low dose Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID

Drug: DE-101 ophthalmic suspension
Ophthalmic suspension; QID
Placebo Comparator: DE-101 ophthalmic suspension vehicle Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID

Drug: DE-101 ophthalmic suspension vehicle
ophthalmic suspension vehicle; QID


Outcome Measures
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Primary Outcome Measures :
  1. Total fluorescein corneal staining [ Time Frame: 8 weeks ]
  2. Ocular Symptom Severity [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118754


Locations
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United States, California
Inglewood, California, United States
Torrance, California, United States
United States, Connecticut
Bloomfield, Connecticut, United States
United States, Indiana
Indianapolis, Indiana, United States
New Albany, Indiana, United States
United States, Louisiana
Gretna, Louisiana, United States
United States, Maine
Bangor, Maine, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Santen Inc.
More Information
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01118754    
Other Study ID Numbers: 26-004
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011
Keywords provided by Santen Inc.:
Santen
Dry
Eye
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases