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

Sponsor

Santen Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03691649

Collaborator

(none)

427

Enrollment

Locations

Arms

25.5

Anticipated Duration (Months)

9.1

Patients Per Site

0.4

Patients Per Site Per Month

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. 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.

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 :

427 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, 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

Actual Study Start Date :

Sep 14, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Oct 30, 2020

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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	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
Active Comparator: 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	Drug: 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

Arm

Intervention/Treatment

Experimental: 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

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

Active Comparator: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

Intraocular pressure [Week 1, Week 6, and Month 3]
Change in IOP

Secondary Outcome Measures

Intraocular pressure [Week 1, Week 6, and 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:

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 Glaucoma Specialists	Phoenix	Arizona	United States	85050
2	DocTrials Walman Eye Center	Sun City	Arizona	United States	85351-3019
3	Havana Research Institute	Burbank	California	United States	91506
4	Macy Eye Center	Los Angeles	California	United States	90048-6149
5	North Valley Eye Medical Group	Mission Hills	California	United States	91345
6	North Bay Eye Associates, Inc	Petaluma	California	United States	94954
7	Martel Eye Medical Group	Rancho Cordova	California	United States	95670
8	Samsum Clinic (DocTrials)	Santa Barbara	California	United States	93110
9	MCB Clinical Research Centers LLC	Colorado Springs	Colorado	United States	80909
10	Hernando Eye Institute	Brooksville	Florida	United States	34613-6065
11	Eye Associates of Fort Myers	Fort Myers	Florida	United States	33901-9311
12	Bowden Eye & Associates	Jacksonville	Florida	United States	32256
13	Shettle Eye Research	Largo	Florida	United States	33773
14	Dixophthal PC Dba. Dixon Eye Care	Albany	Georgia	United States	31701-2363
15	Coastal Research Associates	Alpharetta	Georgia	United States	30076
16	Clayton Eye Clinical Research, LLC	Morrow	Georgia	United States	30260
17	Indiana University	Bloomington	Indiana	United States	47405
18	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas	United States	662204
19	Clinical Eye Research of Boston, LLC	Winchester	Massachusetts	United States	01890
20	Tauber Eye Center	Kansas City	Missouri	United States	64111
21	Nevada Eye Care Professionals	Las Vegas	Nevada	United States	89119
22	Wellish Vision Institute	Las Vegas	Nevada	United States	89119
23	AdvanceMed Clinical Research-Las Vegas	Las Vegas	Nevada	United States	89123-2810
24	Northern New Jersey Eye Institute	South Orange	New Jersey	United States	07079-1855
25	NY Eye & ear Infirmary of Mt Sinai (NYEE)	New York	New York	United States	10003
26	South Shore Eye Care, LLP	Wantagh	New York	United States	11793
27	Asheville Eye Associates	Asheville	North Carolina	United States	28803-2493
28	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina	United States	28210
29	Cornerstone Eye Care	High Point	North Carolina	United States	27262
30	Apex Eye Clinical Research, LLC	Cincinnati	Ohio	United States	45242
31	Ophthalmic Surgeons & Consultants of Ohio, Inc.	Columbus	Ohio	United States	43215
32	Office of Mark J. Weiss MD	Tulsa	Oklahoma	United States	74104-5300
33	Scott & Christie and Associates PC	Cranberry Township	Pennsylvania	United States	16066
34	Glaucoma Consultants and Center for Eye Research PA	Mount Pleasant	South Carolina	United States	29464-8298
35	Black Hills Regional Eye Institute, LLP	Rapid City	South Dakota	United States	57701
36	University Eye Specialists	Maryville	Tennessee	United States	37803
37	Total Eye Care PA	Memphis	Tennessee	United States	38119-5770
38	Keystone Research Ltd. Texan Eye PA	Austin	Texas	United States	78731-4203
39	The Cataract and Glaucoma Center	El Paso	Texas	United States	79902
40	Ophthalmology Associates	Fort Worth	Texas	United States	76102
41	Shah Research LLC dba Discovery Clinical Trials	Mission	Texas	United States	78572-2425
42	San Antonio Eye Center	San Antonio	Texas	United States	78215-1936
43	R and R Eye Research LLC	San Antonio	Texas	United States	78229
44	Delay Winter Eye Consultants LLC	San Antonio	Texas	United States	78230-5141
45	Stacy R. Smith M.D. P.C.	Salt Lake City	Utah	United States	84117-5209
46	Emerson Clinical Research Institute	Falls Church	Virginia	United States	22046
47	Specialty Eye Care Centre	Bellevue	Washington	United States	98004