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

Sponsor
Santen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04742283
Collaborator
(none)
323
41
2
11.7
7.9
0.7

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
  • Drug: DE-126 Ophthalmic Solution 0.002% QD
  • Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
323 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, 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
Actual Study Start Date :
Dec 17, 2020
Actual Primary Completion Date :
Dec 7, 2021
Actual Study Completion Date :
Dec 7, 2021

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

  1. 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.

  2. 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.

  3. 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

  1. Mean Diurnal Intraocular Pressure [Three months]

    Mean diurnal Intraocular Pressure (IOP) in the study eye at Month 3

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT04742283
Other Study ID Numbers:
  • 012604IN
First Posted:
Feb 8, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
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
Keywords provided by Santen Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022