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

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

Sponsors

Lead sponsor: Santen Inc.

Source Santen Inc.
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.

Overall Status Active, not recruiting
Start Date September 27, 2018
Completion Date December 31, 2019
Primary Completion Date December 31, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Intraocular pressure Week 1, Week 6 and Month 3
Secondary Outcome
Measure Time Frame
Intraocular pressure Week 1, Month 3
Enrollment 409
Condition
Intervention

Intervention type: Drug

Intervention name: DE-117 Ophthalmic Solution

Description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months

Arm group label: DE-117 Ophthalmic Solution

Intervention type: Drug

Intervention name: Timolol Maleate Ophthalmic Solution 0.5%

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

Arm group label: Timolol Maleate Ophthalmic Solution 0.5%

Eligibility

Criteria:

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

Gender: All

Minimum age: 12 Months

Maximum age: N/A

Healthy volunteers: No

Location
facility
Arizona Eye Center | Chandler, Arizona, 85224, United States
M & M Eye Institute | Prescott, Arizona, 86301-6610, United States
Global Research Management | Glendale, California, 91204, United States
United Medical Research Inst | Inglewood, California, 90301, United States
Eye Research Foundation | Newport Beach, California, 92663-3642, United States
North Bay Eye Associates Inc. | Petaluma, California, 94954-2387, United States
Sacramento Eye Consultants | Sacramento, California, 95815-4605, United States
AdvanceMed Clinical Research | San Diego, California, 92122, United States
Michael K. Tran, MD, Inc. | Westminster, California, 92683-7071, United States
Haas Vision Center | Colorado Springs, Colorado, 80919-5913, United States
Florida Ophthalmic Institute | Gainesville, Florida, 32605-3192, United States
St. Michaels Eye Laser Institute | Largo, Florida, 33770-3225, United States
International Eye Associates PA | Ormond Beach, Florida, 32174, United States
East Florida Eye Institute | Stuart, Florida, 34994, United States
Clayton Eye Clinical Research, LLC | Morrow, Georgia, 30260, United States
Seidenberg Protzko Eye Associates | Havre De Grace, Maryland, 21078, United States
Great Lakes Eye Care P.C | Saint Joseph, Michigan, 49085, United States
Discover Vision Centers | Independence, Missouri, 64055-6974, United States
Silverstein Eye Centers | Kansas City, Missouri, 64133, United States
Comprehensive Eye Care Ltd. | Washington, Missouri, 63090-3010, United States
AdvanceMed Clinical Research | Las Vegas, Nevada, 89123, United States
Rochester Ophthalmological Group, PC | Rochester, New York, 14618, United States
Asheville Eye Associates | Asheville, North Carolina, 28803-2493, United States
Abrams Eye Center | Cleveland, Ohio, 44115, United States
Total Eye Care PA | Memphis, Tennessee, 38119-5770, United States
VRF Eye Specialty Group | Memphis, Tennessee, 38120, United States
Glaucoma Associates of Texas | Dallas, Texas, 75231-2168, United States
Houston Eye Associates HEA - Gramercy Location | Houston, Texas, 77025-1756, United States
Baylor College of Medicine Alkek Eye Center | Houston, Texas, 77030, United States
The Eye Clinic of Texas | League City, Texas, 77573-5148, United States
Medical Center Ophthalmology Associates | San Antonio, Texas, 78240-1502, United States
Stacy R. Smith M.D. P.C. | Salt Lake City, Utah, 84117, United States
Vistar Eye Center | Roanoke, Virginia, 24016-5100, United States
Tidewater Clinical Research | Virginia Beach, Virginia, 23456, United States
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: DE-117 Ophthalmic Solution

Arm group type: Experimental

Description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months

Arm group label: Timolol Maleate Ophthalmic Solution 0.5%

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov