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

Ocular Hypertension Clinical Trial

— ANGEL-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742283
• Other study ID #: 012604IN
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2020
• Est. completion date: December 7, 2021

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• DE-126 Ophthalmic Solution 0.002% QD
DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
• Timolol Maleate Ophthalmic Solution 0.5% BID
Timolol Maleate Ophthalmic Solution BID (morning and evening)

Locations

Country	Name	City	State
United States	Dixophthal PC dba Dixon Eye Care	Albany	Georgia
United States	University of Colorado, Dept. of Opthamology	Aurora	Colorado
United States	Hernando Eye Institute	Brooksville	Florida
United States	Arizona Eye Center	Chandler	Arizona
United States	Apex Eye Clinical Research, LLC	Cincinnati	Ohio
United States	Scott & Christie and Associates PC	Cranberry Township	Pennsylvania
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Duke Eye Center	Durham	North Carolina
United States	The Cataract and Glaucoma Center	El Paso	Texas
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Global Research Management	Glendale	California
United States	Wake Forest Health Network Ophthamology - Oak Hollow	High Point	North Carolina
United States	Bowden Eye & Associates	Jacksonville	Florida
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Mayo Clinic, Dept. of Opthamology	Jacksonville	Florida
United States	Shettle Eye Research	Largo	Florida
United States	AdvanceMed Clinical Research-Las Vegas	Las Vegas	Nevada
United States	Nevada Eye Care Professionals	Las Vegas	Nevada
United States	Premiere Practice Management	Los Angeles	California
United States	University Eye Specialists	Maryville	Tennessee
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	DCT- Shah Research LLC dba Discovery Clinical Trials	Mission	Texas
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	The Eye Research Foundation	Newport Beach	California
United States	University of California, Los Angeles, Doheny Eye Centers	Pasadena	California
United States	North Bay Eye Associates, Inc	Petaluma	California
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Arizona Glaucoma Specialists	Phoenix	Arizona
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Rochester Ophthalmological Group, P.C.	Rochester	New York
United States	Coastal Research Associates	Roswell	Georgia
United States	Sacramento Eye Consultants	Sacramento	California
United States	Stacy R. Smith M.D. P.C.	Salt Lake City	Utah
United States	R and R Eye Research LLC	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Northern New Jersey Eye Institute	South Orange	New Jersey
United States	Walman Eye Center	Sun City	Arizona
United States	Office of Mark J. Weiss MD	Tulsa	Oklahoma
United States	Vance Thompson Vision - ND	W. Fargo	North Dakota
United States	Clinical Eye Research of Boston, LLC	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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