A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

NCT03691649 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 011709IN
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 47

Brief Summary

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

• DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
• Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.

Conditions

Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (3)

• Intraocular Pressure at Week 1

  Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated 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 1

• Intraocular Pressure at Week 6

  Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated 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 measured with calibrated 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 (5)

• Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)

  Month 3

• Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

  08:00, 10:00 and 16:00 at Week 1

• Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

  08:00, 10:00 and 16:00 at Week 6

• Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

  08:00, 10:00 and 16:00 at Month 3

• Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)

  Week 1

Study Arms (2)

DE-117 Ophthalmic Solution

EXPERIMENTAL

Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Drug: DE-117 Ophthalmic Solution

Timolol Maleate Ophthalmic Solution 0.5%

ACTIVE COMPARATOR

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Drug: Timolol Maleate Ophthalmic Solution 0.5%

Interventions

DE-117 Ophthalmic Solution DRUG

Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

DE-117 Ophthalmic Solution

Timolol Maleate Ophthalmic Solution 0.5% DRUG

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Timolol Maleate Ophthalmic Solution 0.5%

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• glaucoma or ocular hypertension

You may not qualify if:

• Females who are pregnant, nursing, or planning a pregnancy
• Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (47)

Arizona Glaucoma Specialists

Phoenix, Arizona, 85050, United States

Location

DocTrials Walman Eye Center

Sun City, Arizona, 85351-3019, United States

Location

Havana Research Institute

Burbank, California, 91506, United States

Location

Macy Eye Center

Los Angeles, California, 90048-6149, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

North Bay Eye Associates, Inc

Petaluma, California, 94954, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Samsum Clinic (DocTrials)

Santa Barbara, California, 93110, United States

Location

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, 80909, 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

Bowden Eye & Associates

Jacksonville, Florida, 32256, 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

Coastal Research Associates

Alpharetta, Georgia, 30076, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Indiana University

Bloomington, Indiana, 47405, United States

Location

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 662204, United States

Location

Clinical Eye Research of Boston, LLC

Winchester, Massachusetts, 01890, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Nevada Eye Care Professionals

Las Vegas, Nevada, 89119, United States

Location

Wellish Vision Institute

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

NY Eye & ear Infirmary of Mt Sinai (NYEE)

New York, New York, 10003, United States

Location

South Shore Eye Care, LLP

Wantagh, New York, 11793, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803-2493, United States

Location

Charlotte Eye Ear Nose & Throat Associates, PA

Charlotte, North Carolina, 28210, United States

Location

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Location

Apex Eye Clinical Research, LLC

Cincinnati, Ohio, 45242, United States

Location

Ophthalmic Surgeons & Consultants of Ohio, Inc.

Columbus, Ohio, 43215, 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, United States

Location

Glaucoma Consultants and Center for Eye Research PA

Mt. Pleasant, South Carolina, 29464-8298, United States

Location

Black Hills Regional Eye Institute, LLP

Rapid City, South Dakota, 57701, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119-5770, United States

Location

Keystone Research Ltd. Texan Eye PA

Austin, Texas, 78731-4203, United States

Location

The Cataract and Glaucoma Center

El Paso, Texas, 79902, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

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, United States

Location

Delay Winter Eye Consultants LLC

San Antonio, Texas, 78230-5141, United States

Location

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

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

Location

Emerson Clinical Research Institute

Falls Church, Virginia, 22046, United States

Location

Specialty Eye Care Centre

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: September 14, 2018
• Primary Completion: December 6, 2019
• Study Completion: September 3, 2020
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (47)