Back to resultsStudy Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DE-101 ophthalmic suspension
DE-101 ophthalmic suspension
DE-101 ophthalmic suspension vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Santen, Dry, Eye
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
DE-101 ophthalmic suspension high dose
DE-101 ophthalmic suspension low dose
DE-101 ophthalmic suspension vehicle
Arm Description
Outcomes
Primary Outcome Measures
Total fluorescein corneal staining
Ocular Symptom Severity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118754
Brief Title
Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Santen, Dry, Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DE-101 ophthalmic suspension high dose
Arm Type
Experimental
Arm Title
DE-101 ophthalmic suspension low dose
Arm Type
Experimental
Arm Title
DE-101 ophthalmic suspension vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DE-101 ophthalmic suspension
Intervention Description
Ophthalmic suspention; QID
Intervention Type
Drug
Intervention Name(s)
DE-101 ophthalmic suspension
Intervention Description
Ophthalmic suspension; QID
Intervention Type
Drug
Intervention Name(s)
DE-101 ophthalmic suspension vehicle
Intervention Description
ophthalmic suspension vehicle; QID
Primary Outcome Measure Information:
Title
Total fluorescein corneal staining
Time Frame
8 weeks
Title
Ocular Symptom Severity
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Inglewood
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Bloomfield
State/Province
Connecticut
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
New Albany
State/Province
Indiana
Country
United States
City
Gretna
State/Province
Louisiana
Country
United States
City
Bangor
State/Province
Maine
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
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