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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma and Ocular Hypertension
• Intervention / Treatment: Drug: DE-117 Ophthalmic Solution; Drug: Timolol Maleate Ophthalmic Solution 0.5%

• Study Type: Interventional
• Enrollment (Actual): 417
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Prescott, Arizona, United States, 86301-6610
      • M & M Eye Institute
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
    • Inglewood, California, United States, 90301
      • United Medical Research Inst
    • Newport Beach, California, United States, 92663-3642
      • Eye Research Foundation
    • Petaluma, California, United States, 94954-2387
      • North Bay Eye Associates Inc.
    • Sacramento, California, United States, 95815-4605
      • Sacramento Eye Consultants
    • San Diego, California, United States, 92122
      • AdvanceMed Clinical Research
    • Westminster, California, United States, 92683-7071
      • Michael K. Tran, MD, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80919-5913
      • Haas Vision Center
  • Florida
    • Gainesville, Florida, United States, 32605-3192
      • Florida Ophthalmic Institute
    • Largo, Florida, United States, 33770-3225
      • St. Michaels Eye Laser Institute
    • Ormond Beach, Florida, United States, 32174
      • International Eye Associates PA
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care P.C
  • Missouri
    • Independence, Missouri, United States, 64055-6974
      • Discover Vision Centers
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Washington, Missouri, United States, 63090-3010
      • Comprehensive Eye Care Ltd.
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • AdvanceMed Clinical Research
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28803-2493
      • Asheville Eye Associates
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • VRF Eye Specialty Group
    • Memphis, Tennessee, United States, 38119-5770
      • Total Eye Care PA
  • Texas
    • Dallas, Texas, United States, 75231-2168
      • Glaucoma Associates of Texas
    • Houston, Texas, United States, 77025-1756
      • Houston Eye Associates HEA - Gramercy Location
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Alkek Eye Center
    • League City, Texas, United States, 77573-5148
      • The Eye Clinic of Texas
    • San Antonio, Texas, United States, 78240-1502
      • Medical Center Ophthalmology Associates
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Stacy R. Smith M.D. P.C.
  • Virginia
    • Roanoke, Virginia, United States, 24016-5100
      • Vistar Eye Center
    • Virginia Beach, Virginia, United States, 23456
      • Tidewater Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DE-117 Ophthalmic Solution; Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months	Drug: DE-117 Ophthalmic Solution; Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months	Drug: Timolol Maleate Ophthalmic Solution 0.5%; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	08:00, 10:00 and 16:00 at Week 1
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.	08:00, 10:00 and 16:00 at Week 6
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.	08:00, 10:00 and 16:00 at Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	08:00, 10:00 and 16:00 at week 1
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)	08:00, 10:00 and 16:00 at week 6
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)	08:00, 10:00 and 16:00 at month 3
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.	week 1

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): October 23, 2019
• Study Completion (Actual): October 23, 2019

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 011710IN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No