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A Study Assessing the 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:
NCT01468168
First received: November 7, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.


Condition Intervention Phase
Dry Eye Disease
Drug: DE-101 Ophthalmic Suspension
Drug: DE-101 Ophthalmic Suspension Vehicle
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: A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension 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:
  • Tear volume increase from baseline [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: October 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DE-101 Ophthalmic Suspension High Dose Drug: DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
Experimental: DE-101 Ophthalmic Suspension Low Dose Drug: DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle 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:

  • Individuals considered for entry into the study will be of either sex and any race who have:
  • a confirmed diagnosis of dry eye,
  • are willing to use no ocular treatments during the study other than study medication,
  • have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
  • will not use contact lenses during the study,
  • Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
  • 18 years of age or older,
  • able to understand and provide written informed consent

Exclusion Criteria:

  • Subjects with any of the following are not eligible to participate in the study:
  • Fluorescein corneal staining or conjunctival staining that is too severe
  • Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
  • Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
  • Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
  • Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
  • Ocular(including lid)disease/abnormality that may interfere with the study
  • Corneal transplant in either eye, at any time prior to enrollment in the study
  • Laser refractive surgery less than one year prior to Visit 1 (Day 1)
  • Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
  • Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
  • Known allergy or sensitivity to any of the study medication components
  • Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
  • A woman who is pregnant, nursing, or planning a pregnancy
  • Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
  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 ClinicalTrials.gov identifier: NCT01468168

Locations
United States, California
New Port Beach, California, United States, 92663
United States, Colorado
Parker, Colorado, United States, 80134
United States, Florida
Largo, Florida, United States, 33773
United States, Georgia
Morrow, Georgia, United States, 30260
Roswell, Georgia, United States, 30076
United States, Maine
Bangor, Maine, United States, 04401
United States, Missouri
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63131
Washington, Missouri, United States, 63090
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Ohio
Cleveland, Ohio, United States, 44115
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Santen Inc.
  More Information

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01468168     History of Changes
Other Study ID Numbers: 26-005
Study First Received: November 7, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014