ANGEL-2: Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.
This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DE-126 Opthalmic Solution 0.002% QD and Vehicle QD DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) |
Drug: DE-126 Ophthalmic Solution 0.002% QD
DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
Active Comparator: Timolol Maleate Opthalmic Solution 0.5% BID Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) |
Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
Outcome Measures
Primary Outcome Measures
- Intraocular Pressure [08:00, 10:00 and 16:00 at Week 2]
Intraocular pressure (IOP), in the study eye at 3 time-points throughout the day.
- Intraocular Pressure [08:00, 10:00 and 16:00 at Week 6]
Intraocular pressure (IOP), in the study eye at 3 time-points throughout the day.
- Intraocular Pressure [08:00, 10:00 and 16:00 at Month 3]
Intraocular pressure (IOP), in the study eye at 3 time-points throughout the day.
Secondary Outcome Measures
- Mean Diurnal Intraocular Pressure [Three months]
Mean diurnal Intraocular Pressure (IOP) in the study eye at Month 3
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
-
Completed the required wait/washout period
-
Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Exclusion Criteria:
-
Females who are pregnant, nursing, or planning a pregnancy
-
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
-
History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
-
Presence of advanced glaucoma in either eye
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Eye Center | Chandler | Arizona | United States | 85224 |
2 | Arizona Glaucoma Specialists | Phoenix | Arizona | United States | 85050 |
3 | Walman Eye Center | Sun City | Arizona | United States | 85351-3019 |
4 | Global Research Management | Glendale | California | United States | 91204-2569 |
5 | Premiere Practice Management | Los Angeles | California | United States | 90013 |
6 | North Valley Eye Medical Group | Mission Hills | California | United States | 91342 |
7 | The Eye Research Foundation | Newport Beach | California | United States | 92663-3642 |
8 | University of California, Los Angeles, Doheny Eye Centers | Pasadena | California | United States | 91105 |
9 | North Bay Eye Associates, Inc | Petaluma | California | United States | 94954 |
10 | Sacramento Eye Consultants | Sacramento | California | United States | 95815-4605 |
11 | University of Colorado, Dept. of Opthamology | Aurora | Colorado | United States | 80045 |
12 | Hernando Eye Institute | Brooksville | Florida | United States | 34613-6065 |
13 | Eye Associates of Fort Myers | Fort Myers | Florida | United States | 33901-9311 |
14 | Levenson Eye Associates | Jacksonville | Florida | United States | 32204 |
15 | Mayo Clinic, Dept. of Opthamology | Jacksonville | Florida | United States | 32224 |
16 | Bowden Eye & Associates | Jacksonville | Florida | United States | 32258 |
17 | Shettle Eye Research | Largo | Florida | United States | 33773 |
18 | Dixophthal PC dba Dixon Eye Care | Albany | Georgia | United States | 31701-2363 |
19 | Clayton Eye Clinical Research, LLC | Morrow | Georgia | United States | 30260 |
20 | Coastal Research Associates | Roswell | Georgia | United States | 30076 |
21 | Clinical Eye Research of Boston, LLC | Winchester | Massachusetts | United States | 01890 |
22 | Nevada Eye Care Professionals | 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 | Rochester Ophthalmological Group, P.C. | Rochester | New York | United States | 14618 |
26 | Duke Eye Center | Durham | North Carolina | United States | 27705 |
27 | Wake Forest Health Network Ophthamology - Oak Hollow | High Point | North Carolina | United States | 27262-7612 |
28 | Vance Thompson Vision - ND | W. Fargo | North Dakota | United States | 58078 |
29 | Apex Eye Clinical Research, LLC | Cincinnati | Ohio | United States | 45242 |
30 | Office of Mark J. Weiss MD | Tulsa | Oklahoma | United States | 74104-5300 |
31 | Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | United States | 16066-6412 |
32 | Wills Eye Hospital | Philadelphia | Pennsylvania | United States | 19107 |
33 | Black Hills Regional Eye Institute | Rapid City | South Dakota | United States | 57701-7374 |
34 | University Eye Specialists | Maryville | Tennessee | United States | 37803-6100 |
35 | VRF Eye Specialty Group | Memphis | Tennessee | United States | 38120-9411 |
36 | Glaucoma Associates of Texas | Dallas | Texas | United States | 75231-2168 |
37 | The Cataract and Glaucoma Center | El Paso | Texas | United States | 79902 |
38 | DCT- Shah Research LLC dba Discovery Clinical Trials | Mission | Texas | United States | 78572-2425 |
39 | San Antonio Eye Center | San Antonio | Texas | United States | 78215-1936 |
40 | R and R Eye Research LLC | San Antonio | Texas | United States | 78229-3539 |
41 | Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | United States | 84117-5209 |
Sponsors and Collaborators
- Santen Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 012604IN