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Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239069
First Posted: November 11, 2010
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Santen Inc.
  Purpose
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Condition Intervention Phase
Dry Eye Drug: DE-110 ophthalmic suspension high dose Drug: DE-110 ophthalmic suspension low dose Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Efficacy of DE-110 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Individual Response Rate [ Time Frame: 12 weeks ]
  • Individual Efficacy [ Time Frame: 12 weeks ]
  • Individual Symptoms [ Time Frame: 12 weeks ]

Enrollment: 140
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DE-110 ophthalmic suspension high dose Drug: DE-110 ophthalmic suspension high dose
ophthalmic suspension; high dose; QID
Experimental: DE-110 ophthalmic suspension low dose Drug: DE-110 ophthalmic suspension low dose
ophthalmic suspension; low dose; QID
Placebo Comparator: Placebo Other: Placebo
DE-110 ophthalmic suspension vehicle;QID

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Confirmed diagnosis of dry eye
  • Not wear contact lenses during study
  • 18 years or older
  • Understand and provide written consent
  • Negative pregnancy test and use acceptable method of contraception

Exclusion Criteria:

  • Use of any topical ocular medication
  • Any type of ocular surgery
  • Diagnosis of on-going ocular infection and/or allergic conjunctivitis
  • Uncontrolled systemic conditions/lid abnormalities
  • Corneal transplants
  • Females who are pregnant, nursing or planning a pregnancy
  • Participation in another drug trial concurrently or within 30 days prior to study
  Contacts and Locations
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): NCT01239069


Locations
United States, California
Inglewood, California, United States
Newport Beach, California, United States
Petaluma, California, United States
Torrance, California, United States
United States, Connecticut
Bloomfield, Connecticut, United States
United States, Florida
Bradenton, Florida, United States
Brooksville, Florida, United States
Largo, Florida, United States
United States, Georgia
Rosewell, Georgia, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maine
Bangor, Maine, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Santen Inc.
  More Information

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01239069     History of Changes
Other Study ID Numbers: 30-002
First Submitted: November 9, 2010
First Posted: November 11, 2010
Last Update Posted: October 12, 2017
Last Verified: May 2014

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