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Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01118754
First received: April 29, 2010
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Dry Eye
 Drug: DE-101 ophthalmic suspension
Drug: DE-101 ophthalmic suspension vehicle
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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:
  • Total fluorescein corneal staining [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Ocular Symptom Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118754

Locations
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

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01118754     History of Changes
Other Study ID Numbers: 26-004
Study First Received: April 29, 2010
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Santen Inc.:
Santen
Dry
Eye

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