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

NCT04742283 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 012604IN
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 41

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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mean Diurnal Intraocular Pressure at Month 3

  Three months

Study Arms (2)

DE-126 Opthalmic Solution 0.002% QD and Vehicle QD

EXPERIMENTAL

DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)

Drug: DE-126 Ophthalmic Solution 0.002% QD

Timolol Maleate Opthalmic Solution 0.5% BID

ACTIVE COMPARATOR

Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)

Drug: Timolol Maleate Ophthalmic Solution 0.5% BID

Interventions

DE-126 Ophthalmic Solution 0.002% QD DRUG

DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning

DE-126 Opthalmic Solution 0.002% QD and Vehicle QD

Timolol Maleate Ophthalmic Solution 0.5% BID DRUG

Timolol Maleate Ophthalmic Solution BID (morning and evening)

Timolol Maleate Opthalmic Solution 0.5% BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (41)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

Arizona Glaucoma Specialists

Phoenix, Arizona, 85050, United States

Location

Walman Eye Center

Sun City, Arizona, 85351-3019, United States

Location

Global Research Management

Glendale, California, 91204-2569, United States

Location

Premiere Practice Management

Los Angeles, California, 90013, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91342, United States

Location

The Eye Research Foundation

Newport Beach, California, 92663-3642, United States

Location

University of California, Los Angeles, Doheny Eye Centers

Pasadena, California, 91105, United States

Location

North Bay Eye Associates, Inc

Petaluma, California, 94954, United States

Location

Sacramento Eye Consultants

Sacramento, California, 95815-4605, United States

Location

University of Colorado, Dept. of Opthamology

Aurora, Colorado, 80045, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34613-6065, United States

Location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901-9311, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Mayo Clinic, Dept. of Opthamology

Jacksonville, Florida, 32224, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32258, United States

Location

Shettle Eye Research

Largo, Florida, 33773, United States

Location

Dixophthal PC dba Dixon Eye Care

Albany, Georgia, 31701-2363, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Clinical Eye Research of Boston, LLC

Winchester, Massachusetts, 01890, United States

Location

Nevada Eye Care Professionals

Las Vegas, Nevada, 89119, United States

Location

AdvanceMed Clinical Research-Las Vegas

Las Vegas, Nevada, 89123-2810, United States

Location

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079-1855, United States

Location

Rochester Ophthalmological Group, P.C.

Rochester, New York, 14618, United States

Location

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

Wake Forest Health Network Ophthamology - Oak Hollow

High Point, North Carolina, 27262-7612, United States

Location

Vance Thompson Vision - ND

West Fargo, North Dakota, 58078, United States

Location

Apex Eye Clinical Research, LLC

Cincinnati, Ohio, 45242, United States

Location

Office of Mark J. Weiss MD

Tulsa, Oklahoma, 74104-5300, United States

Location

Scott & Christie and Associates PC

Cranberry Township, Pennsylvania, 16066-6412, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701-7374, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803-6100, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120-9411, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231-2168, United States

Location

The Cataract and Glaucoma Center

El Paso, Texas, 79902, United States

Location

DCT- Shah Research LLC dba Discovery Clinical Trials

Mission, Texas, 78572-2425, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215-1936, United States

Location

R and R Eye Research LLC

San Antonio, Texas, 78229-3539, United States

Location

Stacy R. Smith M.D. P.C.

Salt Lake City, Utah, 84117-5209, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Director of R&D Quality Management
• Organization: Santen Inc

evelyn.chikere@santen.com

15106851794

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 8, 2021
• Study Start: December 17, 2020
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: June 22, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)