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

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

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.

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): 426
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Arizona Glaucoma Specialists
    • Sun City, Arizona, United States, 85351-3019
      • DocTrials Walman Eye Center
  • California
    • Burbank, California, United States, 91506
      • Havana Research Institute
    • Los Angeles, California, United States, 90048-6149
      • Macy Eye Center
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Santa Barbara, California, United States, 93110
      • Samsum Clinic (DocTrials)
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • MCB Clinical Research Centers LLC
  • Florida
    • Brooksville, Florida, United States, 34613-6065
      • Hernando Eye Institute
    • Fort Myers, Florida, United States, 33901-9311
      • Eye Associates of Fort Myers
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye & Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
  • Georgia
    • Albany, Georgia, United States, 31701-2363
      • Dixophthal PC Dba. Dixon Eye Care
    • Alpharetta, Georgia, United States, 30076
      • Coastal Research Associates
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University
  • Kansas
    • Shawnee Mission, Kansas, United States, 662204
      • Heart of America Eye Care, P.A.
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston, LLC
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Wellish Vision Institute
    • Las Vegas, Nevada, United States, 89119
      • Nevada Eye Care Professionals
    • Las Vegas, Nevada, United States, 89123-2810
      • AdvanceMed Clinical Research-Las Vegas
  • New Jersey
    • South Orange, New Jersey, United States, 07079-1855
      • Northern New Jersey Eye Institute
  • New York
    • New York, New York, United States, 10003
      • NY Eye & ear Infirmary of Mt Sinai (NYEE)
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care, LLP
  • North Carolina
    • Asheville, North Carolina, United States, 28803-2493
      • Asheville Eye Associates
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose & Throat Associates, PA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Apex Eye Clinical Research, LLC
    • Columbus, Ohio, United States, 43215
      • Ophthalmic Surgeons & Consultants of Ohio, Inc.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104-5300
      • Office of Mark J. Weiss MD
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates PC
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464-8298
      • Glaucoma Consultants and Center for Eye Research PA
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute, LLP
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38119-5770
      • Total Eye Care PA
  • Texas
    • Austin, Texas, United States, 78731-4203
      • Keystone Research Ltd. Texan Eye PA
    • El Paso, Texas, United States, 79902
      • The Cataract and Glaucoma Center
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates
    • Mission, Texas, United States, 78572-2425
      • Shah Research LLC dba Discovery Clinical Trials
    • San Antonio, Texas, United States, 78215-1936
      • San Antonio Eye Center
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research LLC
    • San Antonio, Texas, United States, 78230-5141
      • Delay Winter Eye Consultants LLC
  • Utah
    • Salt Lake City, Utah, United States, 84117-5209
      • Stacy R. Smith M.D. P.C.
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute
  • Washington
    • Bellevue, Washington, United States, 98004
      • Specialty Eye Care Centre

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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	Drug: DE-117 Ophthalmic Solution; 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
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%; 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	Drug: Timolol Maleate Ophthalmic Solution 0.5%; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	08:00, 10:00 and 16:00 at Week 1
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)	08:00, 10:00 and 16:00 at Week 6
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)	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)	Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.	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)	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.	Week 1

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): September 3, 2020

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 30, 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: 011709IN

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