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

This study has been completed.
Information provided by (Responsible Party):
Santen Inc. Identifier:
First received: April 29, 2010
Last updated: November 1, 2011
Last verified: November 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Santen Inc.:

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

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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01118754

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

Responsible Party: Santen Inc. Identifier: NCT01118754     History of Changes
Other Study ID Numbers: 26-004
Study First Received: April 29, 2010
Last Updated: November 1, 2011

Keywords provided by Santen Inc.:

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on June 23, 2017