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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 4 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 Eye Center
  • M & M Eye Institute
  • Global Research Management
  • United Medical Research Inst
  • Eye Research Foundation
  • North Bay Eye Associates Inc.
  • Sacramento Eye Consultants
  • AdvanceMed Clinical Research
  • Michael K. Tran, MD, Inc.
  • Haas Vision Center
  • Florida Ophthalmic Institute
  • St. Michaels Eye Laser Institute
  • International Eye Associates PA
  • East Florida Eye Institute
  • Clayton Eye Clinical Research, LLC
  • Seidenberg Protzko Eye Associates
  • Great Lakes Eye Care P.C
  • Discover Vision Centers
  • Silverstein Eye Centers
  • Comprehensive Eye Care Ltd.
  • AdvanceMed Clinical Research
  • Rochester Ophthalmological Group, PC
  • Asheville Eye Associates
  • Abrams Eye Center
  • Total Eye Care PA
  • VRF Eye Specialty Group
  • Glaucoma Associates of Texas
  • Houston Eye Associates HEA - Gramercy Location
  • Baylor College of Medicine Alkek Eye Center
  • The Eye Clinic of Texas
  • Medical Center Ophthalmology Associates
  • Stacy R. Smith M.D. P.C.
  • Vistar Eye Center
  • Tidewater Clinical Research

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

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP) at Week 1
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.
Intraocular Pressure (IOP) at Week 6
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.
Intraocular Pressure (IOP) at Month 3
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.

Secondary Outcome Measures

Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3.
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)
The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases. Mean Diurnal IOP 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
NCT03691662
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 4 Study
Official Title
A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter 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 4 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
October 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (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. 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.

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
417 (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
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
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
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
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at Week 1
Description
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.
Time Frame
08:00, 10:00 and 16:00 at Week 1
Title
Intraocular Pressure (IOP) at Week 6
Description
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.
Time Frame
08:00, 10:00 and 16:00 at Week 6
Title
Intraocular Pressure (IOP) at Month 3
Description
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.
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
To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3.
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
The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases. Mean Diurnal IOP 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 Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
M & M Eye Institute
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301-6610
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
United Medical Research Inst
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3642
Country
United States
Facility Name
North Bay Eye Associates Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954-2387
Country
United States
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4605
Country
United States
Facility Name
AdvanceMed Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Michael K. Tran, MD, Inc.
City
Westminster
State/Province
California
ZIP/Postal Code
92683-7071
Country
United States
Facility Name
Haas Vision Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919-5913
Country
United States
Facility Name
Florida Ophthalmic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605-3192
Country
United States
Facility Name
St. Michaels Eye Laser Institute
City
Largo
State/Province
Florida
ZIP/Postal Code
33770-3225
Country
United States
Facility Name
International Eye Associates PA
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Great Lakes Eye Care P.C
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055-6974
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Comprehensive Eye Care Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090-3010
Country
United States
Facility Name
AdvanceMed Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803-2493
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5770
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-2168
Country
United States
Facility Name
Houston Eye Associates HEA - Gramercy Location
City
Houston
State/Province
Texas
ZIP/Postal Code
77025-1756
Country
United States
Facility Name
Baylor College of Medicine Alkek Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Eye Clinic of Texas
City
League City
State/Province
Texas
ZIP/Postal Code
77573-5148
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Stacy R. Smith M.D. P.C.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Vistar Eye Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016-5100
Country
United States
Facility Name
Tidewater Clinical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
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 4 Study

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