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

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.
 
ClinicalTrials.gov Identifier: NCT01468168
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Tracking Information
First Submitted Date  ICMJE November 7, 2011
First Posted Date  ICMJE November 9, 2011
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
Tear volume increase from baseline [ Time Frame: baseline and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01468168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Official Title  ICMJE 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
Brief Summary To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Disease
Intervention  ICMJE
  • Drug: DE-101 Ophthalmic Suspension
    Ophthalmic suspension; QID
  • Drug: DE-101 Ophthalmic Suspension Vehicle
    Ophthalmic suspension vehicle; QID
Study Arms  ICMJE
  • Experimental: DE-101 Ophthalmic Suspension High Dose
    Intervention: Drug: DE-101 Ophthalmic Suspension
  • Experimental: DE-101 Ophthalmic Suspension Low Dose
    Intervention: Drug: DE-101 Ophthalmic Suspension
  • Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle
    Intervention: Drug: DE-101 Ophthalmic Suspension Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
183
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2011)
165
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01468168
Other Study ID Numbers  ICMJE 26-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santen Inc.
Study Sponsor  ICMJE Santen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Santen Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP