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A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

Primary Purpose

Glaucoma and Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DE-117 Ophthalmic Solution
Timolol Maleate Ophthalmic Solution 0.5%
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma and Ocular Hypertension

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy
  • Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Sites / Locations

  • Arizona Glaucoma Specialists
  • DocTrials Walman Eye Center
  • Havana Research Institute
  • Macy Eye Center
  • North Valley Eye Medical Group
  • North Bay Eye Associates, Inc
  • Martel Eye Medical Group
  • Samsum Clinic (DocTrials)
  • MCB Clinical Research Centers LLC
  • Hernando Eye Institute
  • Eye Associates of Fort Myers
  • Bowden Eye & Associates
  • Shettle Eye Research
  • Dixophthal PC Dba. Dixon Eye Care
  • Coastal Research Associates
  • Clayton Eye Clinical Research, LLC
  • Indiana University
  • Heart of America Eye Care, P.A.
  • Clinical Eye Research of Boston, LLC
  • Tauber Eye Center
  • Nevada Eye Care Professionals
  • Wellish Vision Institute
  • AdvanceMed Clinical Research-Las Vegas
  • Northern New Jersey Eye Institute
  • NY Eye & ear Infirmary of Mt Sinai (NYEE)
  • South Shore Eye Care, LLP
  • Asheville Eye Associates
  • Charlotte Eye Ear Nose & Throat Associates, PA
  • Cornerstone Eye Care
  • Apex Eye Clinical Research, LLC
  • Ophthalmic Surgeons & Consultants of Ohio, Inc.
  • Office of Mark J. Weiss MD
  • Scott & Christie and Associates PC
  • Glaucoma Consultants and Center for Eye Research PA
  • Black Hills Regional Eye Institute, LLP
  • University Eye Specialists
  • Total Eye Care PA
  • Keystone Research Ltd. Texan Eye PA
  • The Cataract and Glaucoma Center
  • Ophthalmology Associates
  • Shah Research LLC dba Discovery Clinical Trials
  • San Antonio Eye Center
  • R and R Eye Research LLC
  • Delay Winter Eye Consultants LLC
  • Stacy R. Smith M.D. P.C.
  • Emerson Clinical Research Institute
  • Specialty Eye Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DE-117 Ophthalmic Solution

Timolol Maleate Ophthalmic Solution 0.5%

Arm Description

Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Outcomes

Primary Outcome Measures

Intraocular Pressure at Week 1
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Week 6
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Month 3
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)

Secondary Outcome Measures

Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.

Full Information

First Posted
September 28, 2018
Last Updated
August 8, 2023
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03691649
Brief Title
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
Official Title
A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
September 3, 2020 (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
This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: DE-117 Ophthalmic Solution once daily and Vehicle once daily, or Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DE-117 Ophthalmic Solution
Arm Type
Experimental
Arm Description
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Arm Title
Timolol Maleate Ophthalmic Solution 0.5%
Arm Type
Active Comparator
Arm Description
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Intervention Type
Drug
Intervention Name(s)
DE-117 Ophthalmic Solution
Intervention Description
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate Ophthalmic Solution 0.5%
Intervention Description
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Primary Outcome Measure Information:
Title
Intraocular Pressure at Week 1
Description
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Time Frame
08:00, 10:00 and 16:00 at Week 1
Title
Intraocular Pressure at Week 6
Description
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Time Frame
08:00, 10:00 and 16:00 at Week 6
Title
Intraocular Pressure at Month 3
Description
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Time Frame
08:00, 10:00 and 16:00 at Month 3
Secondary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
Description
Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Time Frame
Month 3
Title
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Description
Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Time Frame
08:00, 10:00 and 16:00 at Week 1
Title
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Description
Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Time Frame
08:00, 10:00 and 16:00 at Week 6
Title
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Description
Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Time Frame
08:00, 10:00 and 16:00 at Month 3
Title
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
Description
Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • glaucoma or ocular hypertension Exclusion Criteria: Females who are pregnant, nursing, or planning a pregnancy Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
Facility Information:
Facility Name
Arizona Glaucoma Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
DocTrials Walman Eye Center
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351-3019
Country
United States
Facility Name
Havana Research Institute
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Macy Eye Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-6149
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
North Bay Eye Associates, Inc
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
Samsum Clinic (DocTrials)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
MCB Clinical Research Centers LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613-6065
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-9311
Country
United States
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Dixophthal PC Dba. Dixon Eye Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701-2363
Country
United States
Facility Name
Coastal Research Associates
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Heart of America Eye Care, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
662204
Country
United States
Facility Name
Clinical Eye Research of Boston, LLC
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Nevada Eye Care Professionals
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
AdvanceMed Clinical Research-Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123-2810
Country
United States
Facility Name
Northern New Jersey Eye Institute
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079-1855
Country
United States
Facility Name
NY Eye & ear Infirmary of Mt Sinai (NYEE)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
South Shore Eye Care, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803-2493
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eye 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
Ophthalmic Surgeons & Consultants of Ohio, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Office of Mark J. Weiss MD
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104-5300
Country
United States
Facility Name
Scott & Christie and Associates PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research PA
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464-8298
Country
United States
Facility Name
Black Hills Regional Eye Institute, LLP
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5770
Country
United States
Facility Name
Keystone Research Ltd. Texan Eye PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4203
Country
United States
Facility Name
The Cataract and Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Facility Name
Shah Research LLC dba Discovery Clinical Trials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572-2425
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215-1936
Country
United States
Facility Name
R and R Eye Research LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Delay Winter Eye Consultants LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230-5141
Country
United States
Facility Name
Stacy R. Smith M.D. P.C.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117-5209
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Specialty Eye Care Centre
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

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