DE-117 Spectrum 5 Study
An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study
1 other identifier
interventional
107
1 country
32
Brief Summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2018
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2018
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedResults Posted
Study results publicly available
August 30, 2023
CompletedAugust 30, 2023
August 1, 2023
3.3 years
October 3, 2018
June 28, 2023
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Month 3
Secondary Outcomes (8)
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
week 2, 6 and month 3
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
week 2 and 6
Change From Baseline in IOP at Timepoints at Week 2
08:00, 12:00 and 16:00 at Week 2
Change From Baseline in IOP at Timepoints at Week 6
08:00, 12:00 and 16:00 at Week 6
Change From Baseline in IOP at Timepoints at Month 3
08:00, 12:00 and 16:00 at month 3
- +3 more secondary outcomes
Study Arms (1)
DE-117 Ophthalmic Solution 0.002%
EXPERIMENTALInterventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Interventions
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Eligibility Criteria
You may qualify if:
- Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
- Provide signed written informed consent.
- Diagnosis of POAG or OHT in both eyes.
- Qualifying corrected visual acuity in each eye.
- Qualifying central corneal thickness in each eye.
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
- Qualifying Anterior chamber angle.
- Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
You may not qualify if:
- Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
- Patients with prior exposure to DE-117.
- History of ocular surgery specifically intended to lower IOP
- Advanced glaucoma in either eye.
- Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
- Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
- Females who are pregnant, nursing, or planning a pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (32)
Arizona Eye Center
Chandler, Arizona, 85225, United States
Global Research Management
Glendale, California, 91204, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810, United States
Shettle Eye Research, Inc.
Largo, Florida, 33773, United States
International Eye Associates, PA
Ormond Beach, Florida, 32174, United States
Dixon Eye Care
Albany, Georgia, 31701-2363, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260, United States
Coastal Research Associates, LEC
Roswell, Georgia, 30076, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
Comprehensive Eye Care Ltd
Washington, Missouri, 63090, United States
NYU Langone Health Department of Ophthalmology
New York, New York, 10017, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
South Shore Eye Center
Wantagh, New York, 14618, United States
Asheville Eye Associates, PLLC
Asheville, North Carolina, 28803, United States
Mundorf Eye Center
Charlotte, North Carolina, 28204, United States
Cornerstone Health Care
High Point, North Carolina, 27262, United States
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, 45242, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
The Eye Institute
Tulsa, Oklahoma, 74104, United States
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, 16066-6412, United States
Glaucoma Consultants and Center for Eye Research, PA
Mt. Pleasant, South Carolina, 29464, United States
Total Eye Care PA
Memphis, Tennessee, 38119, United States
VRF Eye Specialty Group
Memphis, Tennessee, 38120, United States
Nashville Vision Associates
Nashville, Tennessee, 37205, United States
Texas Eye, PA
Austin, Texas, 78731, United States
Eye Clinic of Texas
League City, Texas, 77573, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Related Publications (1)
Panarelli JF, Bowden EC, Tepedino ME, Odani-Kawabata N, Pei Z, McLaurin EB, Ropo A. Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study. J Glaucoma. 2023 Dec 1;32(12):999-1005. doi: 10.1097/IJG.0000000000002321. Epub 2023 Oct 17.
PMID: 37853676DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of R&D Quality Management
- Organization
- Santen Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 5, 2018
Study Start
September 27, 2018
Primary Completion
January 13, 2022
Study Completion
January 13, 2022
Last Updated
August 30, 2023
Results First Posted
August 30, 2023
Record last verified: 2023-08