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

• Sponsor: Santen Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03691662
• Collaborator: (none)
• Enrollment: 409
• Locations: 34
• Arms: 2
• Anticipated Duration (Months): 15.1
• Patients Per Site: 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma and Ocular Hypertension	Drug: DE-117 Ophthalmic Solution; Drug: Timolol Maleate Ophthalmic Solution 0.5%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 409 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 27, 2018
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-117 Ophthalmic Solution Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months	Drug: DE-117 Ophthalmic Solution; Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5% Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months	Drug: Timolol Maleate Ophthalmic Solution 0.5%; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure [Week 1, Week 6 and Month 3]

   Change in IOP

Secondary Outcome Measures

1. Intraocular pressure [Week 1, Month 3]

   Decrease in mean diurnal IOP reduction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Santen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Inc.
• ClinicalTrials.gov Identifier: NCT03691662
• Other Study ID Numbers: 011710IN
• First Posted: Oct 2, 2018
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Dec 16, 2019