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

Glaucoma and Ocular Hypertension Clinical Trial

Official title:

A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691649
• Other study ID #: 011709IN
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2018
• Est. completion date: September 3, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 3, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• DE-117 Ophthalmic Solution
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
• Timolol Maleate Ophthalmic Solution 0.5%
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

Locations

Country	Name	City	State
United States	Dixophthal PC Dba. Dixon Eye Care	Albany	Georgia
United States	Coastal Research Associates	Alpharetta	Georgia
United States	Asheville Eye Associates	Asheville	North Carolina
United States	Keystone Research Ltd. Texan Eye PA	Austin	Texas
United States	Specialty Eye Care Centre	Bellevue	Washington
United States	Indiana University	Bloomington	Indiana
United States	Hernando Eye Institute	Brooksville	Florida
United States	Havana Research Institute	Burbank	California
United States	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina
United States	Apex Eye Clinical Research, LLC	Cincinnati	Ohio
United States	MCB Clinical Research Centers LLC	Colorado Springs	Colorado
United States	Ophthalmic Surgeons & Consultants of Ohio, Inc.	Columbus	Ohio
United States	Scott & Christie and Associates PC	Cranberry Township	Pennsylvania
United States	The Cataract and Glaucoma Center	El Paso	Texas
United States	Emerson Clinical Research Institute	Falls Church	Virginia
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Bowden Eye & Associates	Jacksonville	Florida
United States	Tauber Eye Center	Kansas City	Missouri
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	Wellish Vision Institute	Las Vegas	Nevada
United States	Macy Eye Center	Los Angeles	California
United States	University Eye Specialists	Maryville	Tennessee
United States	Total Eye Care PA	Memphis	Tennessee
United States	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	Glaucoma Consultants and Center for Eye Research PA	Mount Pleasant	South Carolina
United States	NY Eye & ear Infirmary of Mt Sinai (NYEE)	New York	New York
United States	North Bay Eye Associates, Inc	Petaluma	California
United States	Arizona Glaucoma Specialists	Phoenix	Arizona
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Black Hills Regional Eye Institute, LLP	Rapid City	South Dakota
United States	Stacy R. Smith M.D. P.C.	Salt Lake City	Utah
United States	Delay Winter Eye Consultants LLC	San Antonio	Texas
United States	R and R Eye Research LLC	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Samsum Clinic (DocTrials)	Santa Barbara	California
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
United States	Northern New Jersey Eye Institute	South Orange	New Jersey
United States	DocTrials Walman Eye Center	Sun City	Arizona
United States	Office of Mark J. Weiss MD	Tulsa	Oklahoma
United States	South Shore Eye Care, LLP	Wantagh	New York
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 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
Primary	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
Primary	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	Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)	Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.	Month 3
Secondary	Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	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
Secondary	Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	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
Secondary	Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)	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
Secondary	Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)	Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.; Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.	Week 1