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DE-117 Spectrum 5 Study

Primary Purpose

Primary Open-angle Glaucoma and Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DE-117 Ophthalmic Solution
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma and Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
  • Provide signed written informed consent.
  • Diagnosis of POAG or OHT in both eyes.
  • Qualifying corrected visual acuity in each eye.
  • Qualifying central corneal thickness in each eye.
  • Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
  • Qualifying Anterior chamber angle.

Exclusion Criteria:

  • Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
  • Patients with prior exposure to DE-117.
  • History of ocular surgery specifically intended to lower IOP
  • Advanced glaucoma in either eye.
  • Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
  • Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
  • Females who are pregnant, nursing, or planning a pregnancy.

Sites / Locations

  • Arizona Eye Center
  • Global Research Management
  • North Valley Eye Medical Group
  • Eye Research Foundation
  • North Bay Eye Associates
  • Martel Eye Medical Group
  • Danbury Eye Physicians & Surgeons
  • Shettle Eye Research, Inc.
  • International Eye Associates, PA
  • Dixon Eye Care
  • Clayton Eye Clinical Research, LLC
  • Coastal Research Associates, LEC
  • Heart of America Eye Care, P.A.
  • Tekwani Vision Center
  • Comprehensive Eye Care Ltd
  • NYU Langone Health Department of Ophthalmology
  • Rochester Ophthalmological Group, PC
  • South Shore Eye Center
  • Asheville Eye Associates, PLLC
  • Mundorf Eye Center
  • Cornerstone Health Care
  • Apex Eye Clinical Research, LLC
  • Abrams Eye Center
  • The Eye Institute
  • Scott & Christie and Associates PC
  • Glaucoma Consultants and Center for Eye Research, PA
  • Total Eye Care PA
  • VRF Eye Specialty Group
  • Nashville Vision Associates
  • Texas Eye, PA
  • Eye Clinic of Texas
  • Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DE-117 Ophthalmic Solution 0.002%

Arm Description

Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.

Secondary Outcome Measures

Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Change From Baseline in IOP at Timepoints at Week 2
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Change From Baseline in IOP at Timepoints at Week 6
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Change From Baseline in IOP at Timepoints at Month 3
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.

Full Information

First Posted
October 3, 2018
Last Updated
August 8, 2023
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03697811
Brief Title
DE-117 Spectrum 5 Study
Official Title
An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma and Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DE-117 Ophthalmic Solution 0.002%
Arm Type
Experimental
Arm Description
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Intervention Type
Drug
Intervention Name(s)
DE-117 Ophthalmic Solution
Intervention Description
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
Description
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Description
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Time Frame
week 2, 6 and month 3
Title
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Description
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Time Frame
week 2 and 6
Title
Change From Baseline in IOP at Timepoints at Week 2
Description
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Time Frame
08:00, 12:00 and 16:00 at Week 2
Title
Change From Baseline in IOP at Timepoints at Week 6
Description
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Time Frame
08:00, 12:00 and 16:00 at Week 6
Title
Change From Baseline in IOP at Timepoints at Month 3
Description
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Time Frame
08:00, 12:00 and 16:00 at month 3
Title
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Description
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time Frame
08:00, 12:00 and 16:00 at week 2
Title
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Description
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time Frame
08:00, 12:00 and 16:00 at week 6
Title
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Description
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time Frame
08:00, 12:00 and 16:00 at month 3.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes. Provide signed written informed consent. Diagnosis of POAG or OHT in both eyes. Qualifying corrected visual acuity in each eye. Qualifying central corneal thickness in each eye. Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period. Qualifying Anterior chamber angle. Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period. Exclusion Criteria: Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout. Patients with prior exposure to DE-117. History of ocular surgery specifically intended to lower IOP Advanced glaucoma in either eye. Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry. Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye. Females who are pregnant, nursing, or planning a pregnancy.
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Shettle Eye Research, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
International Eye Associates, PA
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dixon Eye Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701-2363
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates, LEC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Heart of America Eye Care, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Comprehensive Eye Care Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
NYU Langone Health Department of Ophthalmology
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
South Shore Eye Center
City
Wantagh
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Eye Associates, PLLC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cornerstone Health Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Apex Eye Clinical Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
The Eye Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Scott & Christie and Associates PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066-6412
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research, PA
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texas Eye, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Eye Clinic of Texas
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

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DE-117 Spectrum 5 Study

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