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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:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01239069
First received: November 9, 2010
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Efficacy of DE-110 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Individual Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Individual Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01239069     History of Changes
Other Study ID Numbers: 30-002
Study First Received: November 9, 2010
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013