DE-117 Spectrum 5 Study

Primary Open-angle Glaucoma and Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697811
• Other study ID #: 011711IN
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2018
• Est. completion date: January 13, 2022

Study information

• Verified date: August 2023
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma and Ocular Hypertension

Intervention

Drug:
• DE-117 Ophthalmic Solution
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.

Locations

Country	Name	City	State
United States	Dixon Eye Care	Albany	Georgia
United States	Asheville Eye Associates, PLLC	Asheville	North Carolina
United States	Texas Eye, PA	Austin	Texas
United States	Arizona Eye Center	Chandler	Arizona
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Apex Eye Clinical Research, LLC	Cincinnati	Ohio
United States	Abrams Eye Center	Cleveland	Ohio
United States	Scott & Christie and Associates PC	Cranberry Township	Pennsylvania
United States	Danbury Eye Physicians & Surgeons	Danbury	Connecticut
United States	Global Research Management	Glendale	California
United States	Cornerstone Health Care	High Point	North Carolina
United States	Shettle Eye Research, Inc.	Largo	Florida
United States	Eye Clinic of Texas	League City	Texas
United States	Total Eye Care PA	Memphis	Tennessee
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Glaucoma Consultants and Center for Eye Research, PA	Mount Pleasant	South Carolina
United States	Nashville Vision Associates	Nashville	Tennessee
United States	NYU Langone Health Department of Ophthalmology	New York	New York
United States	Eye Research Foundation	Newport Beach	California
United States	International Eye Associates, PA	Ormond Beach	Florida
United States	North Bay Eye Associates	Petaluma	California
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Coastal Research Associates, LEC	Roswell	Georgia
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
United States	The Eye Institute	Tulsa	Oklahoma
United States	South Shore Eye Center	Wantagh	New York
United States	Comprehensive Eye Care Ltd	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3	The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.	week 2, 6 and month 3
Secondary	Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6	Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).	week 2 and 6
Secondary	Change From Baseline in IOP at Timepoints at Week 2	Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).	08:00, 12:00 and 16:00 at Week 2
Secondary	Change From Baseline in IOP at Timepoints at Week 6	Change in mean IOP were evaluated at each time point at all post-baseline visits.	08:00, 12:00 and 16:00 at Week 6
Secondary	Change From Baseline in IOP at Timepoints at Month 3	Change in mean IOP were evaluated at each time point at all post-baseline visits.	08:00, 12:00 and 16:00 at month 3
Secondary	Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.	08:00, 12:00 and 16:00 at week 2
Secondary	Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.	08:00, 12:00 and 16:00 at week 6
Secondary	Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.	08:00, 12:00 and 16:00 at month 3.