Back to resultsA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
Primary Purpose
Glaucoma and Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DE-117
0.0015% tafluprost
DE-117 and 0.0015% tafluprost
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma and Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Male or Female, 18 years of age or older
- Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Qualifying intraocular pressure (IOP) in at least one eye at Baseline
Exclusion Criteria:
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
- Females who are pregnant, nursing or planning a pregnancy
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Sites / Locations
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
- Santen Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Low Dose DE-117
Medium Dose DE-117
High Dose DE-117
Low Dose DE-117 and 0.0015% tafluprost
Med. Dose DE-117 and 0.0015% tafluprost
High Dose DE-117 and 0.0015% tafluprost
0.0015% tafluprost
Placebo
Arm Description
Monotherapy
Monotherapy
Monotherapy
Adjunctive Therapy
Adjunctive Therapy
Adjunctive Therapy
Monotherapy
Monotherapy
Outcomes
Primary Outcome Measures
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01654484
Brief Title
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
Official Title
A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (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 investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed Description
This is a two stage study.
Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma and Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose DE-117
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
Medium Dose DE-117
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
High Dose DE-117
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
Low Dose DE-117 and 0.0015% tafluprost
Arm Type
Experimental
Arm Description
Adjunctive Therapy
Arm Title
Med. Dose DE-117 and 0.0015% tafluprost
Arm Type
Experimental
Arm Description
Adjunctive Therapy
Arm Title
High Dose DE-117 and 0.0015% tafluprost
Arm Type
Experimental
Arm Description
Adjunctive Therapy
Arm Title
0.0015% tafluprost
Arm Type
Active Comparator
Arm Description
Monotherapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monotherapy
Intervention Type
Drug
Intervention Name(s)
DE-117
Intervention Description
Ophthalmic Solution, QD, 28 Days
Intervention Type
Drug
Intervention Name(s)
0.0015% tafluprost
Intervention Description
Ophthalmic Solution, QD, 28 days
Intervention Type
Drug
Intervention Name(s)
DE-117 and 0.0015% tafluprost
Intervention Description
Ophthalmic Solutions, QD, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ophthalmic Solution, QD, 28 days
Primary Outcome Measure Information:
Title
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
Time Frame
Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female, 18 years of age or older
Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
Qualifying intraocular pressure (IOP) in at least one eye at Baseline
Exclusion Criteria:
Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
Females who are pregnant, nursing or planning a pregnancy
Presence of any abnormality or significant illness that could be expected to interfere with the study.
Facility Information:
Facility Name
Santen Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Santen Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Santen Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Santen Investigational Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Santen Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Santen Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Santen Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Santen Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Santen Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Facility Name
Santen Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
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A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
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