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

Phase 3

Completed

Conditions: Glaucoma and Ocular Hypertension

Interventions: Drug: Timolol Maleate Ophthalmic Solution 0.5%
Drug: DE-117 Ophthalmic Solution

Registration Number: NCT03691662

Lead Sponsor: Santen Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 417

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol Maleate Ophthalmic Solution 0.5%	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
DE-117 Ophthalmic Solution	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at Week 1	08:00, 10:00 and 16:00 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	08:00, 10:00 and 16:00 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	08:00, 10:00 and 16:00 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

Name	Time	Method
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	08:00, 10:00 and 16:00 at week 1	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)	08:00, 10:00 and 16:00 at week 6	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)	08:00, 10:00 and 16:00 at month 3	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 Month 3 (First Key Secondary Endpoint)	Month 3	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.
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)	week 1	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.

Trial Locations

Locations (33): North Bay Eye Associates Inc.
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Petaluma, California, United States
East Florida Eye Institute
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Stuart, Florida, United States
Vistar Eye Center
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Roanoke, Virginia, United States
M & M Eye Institute
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Prescott, Arizona, United States
Arizona Eye Center
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Chandler, Arizona, United States
Total Eye Care PA
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Memphis, Tennessee, United States
Florida Ophthalmic Institute
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Gainesville, Florida, United States
Global Research Management
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Glendale, California, United States
United Medical Research Inst
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Inglewood, California, United States
Haas Vision Center
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Colorado Springs, Colorado, United States
St. Michaels Eye Laser Institute
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Largo, Florida, United States
International Eye Associates PA
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Ormond Beach, Florida, United States
Discover Vision Centers
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Independence, Missouri, United States
Great Lakes Eye Care P.C
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Saint Joseph, Michigan, United States
Clayton Eye Clinical Research, LLC
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Morrow, Georgia, United States
Seidenberg Protzko Eye Associates
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Havre De Grace, Maryland, United States
Rochester Ophthalmological Group, PC
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Rochester, New York, United States
Comprehensive Eye Care Ltd.
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Washington, Missouri, United States
VRF Eye Specialty Group
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Memphis, Tennessee, United States
The Eye Clinic of Texas
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League City, Texas, United States
Silverstein Eye Centers
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Kansas City, Missouri, United States
Asheville Eye Associates
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Asheville, North Carolina, United States
Glaucoma Associates of Texas
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Dallas, Texas, United States
Houston Eye Associates HEA - Gramercy Location
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Houston, Texas, United States
Baylor College of Medicine Alkek Eye Center
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Houston, Texas, United States
Stacy R. Smith M.D. P.C.
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Salt Lake City, Utah, United States
Tidewater Clinical Research
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Virginia Beach, Virginia, United States
Abrams Eye Center
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Cleveland, Ohio, United States
Medical Center Ophthalmology Associates
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San Antonio, Texas, United States
Eye Research Foundation
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Newport Beach, California, United States
Sacramento Eye Consultants
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Sacramento, California, United States
AdvanceMed Clinical Research
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Las Vegas, Nevada, United States
Michael K. Tran, MD, Inc.
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Westminster, California, United States