Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (ANGEL-2)

A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: DE-126 Ophthalmic Solution 0.002% QD; Drug: Timolol Maleate Ophthalmic Solution 0.5% BID

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Phoenix, Arizona, United States, 85050
      • Arizona Glaucoma Specialists
    • Sun City, Arizona, United States, 85351-3019
      • Walman Eye Center
  • California
    • Glendale, California, United States, 91204-2569
      • Global Research Management
    • Los Angeles, California, United States, 90013
      • Premiere Practice Management
    • Mission Hills, California, United States, 91342
      • North Valley Eye Medical Group
    • Newport Beach, California, United States, 92663-3642
      • The Eye Research Foundation
    • Pasadena, California, United States, 91105
      • University of California, Los Angeles, Doheny Eye Centers
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc
    • Sacramento, California, United States, 95815-4605
      • Sacramento Eye Consultants
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Dept. of Opthamology
  • 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, 32204
      • Levenson Eye Associates
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic, Dept. of Opthamology
    • Jacksonville, Florida, United States, 32258
      • Bowden Eye & Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
  • Georgia
    • Albany, Georgia, United States, 31701-2363
      • Dixophthal PC dba Dixon Eye Care
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston, LLC
  • Nevada
    • 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
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, P.C.
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center
    • High Point, North Carolina, United States, 27262-7612
      • Wake Forest Health Network Ophthamology - Oak Hollow
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision - ND
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Apex Eye Clinical Research, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104-5300
      • Office of Mark J. Weiss MD
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066-6412
      • Scott & Christie and Associates PC
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701-7374
      • Black Hills Regional Eye Institute
  • Tennessee
    • Maryville, Tennessee, United States, 37803-6100
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38120-9411
      • VRF Eye Specialty Group
  • Texas
    • Dallas, Texas, United States, 75231-2168
      • Glaucoma Associates of Texas
    • El Paso, Texas, United States, 79902
      • The Cataract and Glaucoma Center
    • Mission, Texas, United States, 78572-2425
      • DCT- Shah Research LLC dba Discovery Clinical Trials
    • San Antonio, Texas, United States, 78215-1936
      • San Antonio Eye Center
    • San Antonio, Texas, United States, 78229-3539
      • R and R Eye Research LLC
  • Utah
    • Salt Lake City, Utah, United States, 84117-5209
      • Stacy R. Smith M.D. P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
• Completed the required wait/washout period
• Qualifying Day 1 IOP measurement at 3 time-points in both eyes

Exclusion Criteria:

• Females who are pregnant, nursing, or planning a pregnancy
• Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
• History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
• Presence of advanced glaucoma in either eye

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DE-126 Opthalmic Solution 0.002% QD and Vehicle QD; DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)	Drug: DE-126 Ophthalmic Solution 0.002% QD; DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
Active Comparator: Timolol Maleate Opthalmic Solution 0.5% BID; Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)	Drug: Timolol Maleate Ophthalmic Solution 0.5% BID; Timolol Maleate Ophthalmic Solution BID (morning and evening)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the 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 2
Intraocular Pressure at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the 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 measure by the 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 at Month 3	Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.	Three months

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; 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: 012604IN

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