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

Phase 2

Completed

Interventions: Drug: DE-126 Ophthalmic Solution 0.002% QD
Drug: Timolol Maleate Ophthalmic Solution 0.5% BID

Brief 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 & 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

Arm && Interventions

Group	Intervention	Description
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD	DE-126 Ophthalmic Solution 0.002% QD	DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
Timolol Maleate Opthalmic Solution 0.5% BID	Timolol Maleate Ophthalmic Solution 0.5% BID	Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure at Week 2	08:00, 10:00 and 16:00 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).
Intraocular Pressure at Week 6	08:00, 10:00 and 16:00 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).
Intraocular Pressure at Month 3	08:00, 10:00 and 16:00 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).

Secondary Outcome Measures

Name	Time	Method
Mean Diurnal Intraocular Pressure at Month 3	Three months	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.

Locations (41): Arizona Eye Center
🇺🇸
Chandler, Arizona, United States
Arizona Glaucoma Specialists
🇺🇸
Phoenix, Arizona, United States
Walman Eye Center
🇺🇸
Sun City, Arizona, United States
Global Research Management
🇺🇸
Glendale, California, United States
Premiere Practice Management
🇺🇸
Los Angeles, California, United States
North Valley Eye Medical Group
🇺🇸
Mission Hills, California, 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
Sacramento Eye Consultants
🇺🇸
Sacramento, California, United States
Scroll for more (31 remaining)
Arizona Eye Center
🇺🇸Chandler, Arizona, United States