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 4 Study

NCT03691662 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 011710IN
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 34

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. 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.

Conditions

Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (3)

• Intraocular Pressure (IOP) at Week 1

  Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.

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

• Intraocular Pressure (IOP) at Week 6

  Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.

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

• Intraocular Pressure (IOP) at Month 3

  Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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.

  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

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

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

DE-117 Ophthalmic Solution

Timolol Maleate Ophthalmic Solution 0.5% DRUG

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

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 (34)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

M & M Eye Institute

Prescott, Arizona, 86301-6610, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

United Medical Research Inst

Inglewood, California, 90301, United States

Location

Eye Research Foundation

Newport Beach, California, 92663-3642, United States

Location

North Bay Eye Associates Inc.

Petaluma, California, 94954-2387, United States

Location

Sacramento Eye Consultants

Sacramento, California, 95815-4605, United States

Location

AdvanceMed Clinical Research

San Diego, California, 92122, United States

Location

Michael K. Tran, MD, Inc.

Westminster, California, 92683-7071, United States

Location

Haas Vision Center

Colorado Springs, Colorado, 80919-5913, United States

Location

Florida Ophthalmic Institute

Gainesville, Florida, 32605-3192, United States

Location

St. Michaels Eye Laser Institute

Largo, Florida, 33770-3225, United States

Location

International Eye Associates PA

Ormond Beach, Florida, 32174, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Great Lakes Eye Care P.C

Saint Joseph, Michigan, 49085, United States

Location

Discover Vision Centers

Independence, Missouri, 64055-6974, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Comprehensive Eye Care Ltd.

Washington, Missouri, 63090-3010, United States

Location

AdvanceMed Clinical Research

Las Vegas, Nevada, 89123, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803-2493, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119-5770, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231-2168, United States

Location

Houston Eye Associates HEA - Gramercy Location

Houston, Texas, 77025-1756, United States

Location

Baylor College of Medicine Alkek Eye Center

Houston, Texas, 77030, United States

Location

The Eye Clinic of Texas

League City, Texas, 77573-5148, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240-1502, United States

Location

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

Salt Lake City, Utah, 84117, United States

Location

Vistar Eye Center

Roanoke, Virginia, 24016-5100, United States

Location

Tidewater Clinical Research

Virginia Beach, Virginia, 23456, 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 27, 2018
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: August 9, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)