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

Glaucoma and Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691662
• Other study ID #: 011710IN
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2018
• Est. completion date: October 23, 2019

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 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
• Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Locations

Country	Name	City	State
United States	Asheville Eye Associates	Asheville	North Carolina
United States	Arizona Eye Center	Chandler	Arizona
United States	Abrams Eye Center	Cleveland	Ohio
United States	Haas Vision Center	Colorado Springs	Colorado
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Florida Ophthalmic Institute	Gainesville	Florida
United States	Global Research Management	Glendale	California
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Baylor College of Medicine Alkek Eye Center	Houston	Texas
United States	Houston Eye Associates HEA - Gramercy Location	Houston	Texas
United States	Discover Vision Centers	Independence	Missouri
United States	United Medical Research Inst	Inglewood	California
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	St. Michaels Eye Laser Institute	Largo	Florida
United States	AdvanceMed Clinical Research	Las Vegas	Nevada
United States	The Eye Clinic of Texas	League City	Texas
United States	Total Eye Care PA	Memphis	Tennessee
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	International Eye Associates PA	Ormond Beach	Florida
United States	North Bay Eye Associates Inc.	Petaluma	California
United States	M & M Eye Institute	Prescott	Arizona
United States	Vistar Eye Center	Roanoke	Virginia
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Sacramento Eye Consultants	Sacramento	California
United States	Great Lakes Eye Care P.C	Saint Joseph	Michigan
United States	Stacy R. Smith M.D. P.C.	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	AdvanceMed Clinical Research	San Diego	California
United States	East Florida Eye Institute	Stuart	Florida
United States	Tidewater Clinical Research	Virginia Beach	Virginia
United States	Comprehensive Eye Care Ltd.	Washington	Missouri
United States	Michael K. Tran, MD, Inc.	Westminster	California

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 (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
Primary	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
Primary	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	Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)	To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3.	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)	The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases.; Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.	week 1