Primary Open Angle GlaucomaPhase 2ANGEL-2NCT04742283

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

A Phase 2 study testing DE-126 Ophthalmic Solution 0.002% QD and Timolol Maleate Ophthalmic Solution 0.5% BID in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Ocular Hypertension
What is being tested?: DE-126 Ophthalmic Solution 0.002% QD and Timolol Maleate Ophthalmic Solution 0.5% BID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 41 sitesUnited States
Study dates: 17 Dec 2020to 7 Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Dixophthal PC dba Dixon Eye Care
Albany, Georgia, 31701-2363
University of Colorado, Dept. of Opthamology
Aurora, Colorado, 80045
Hernando Eye Institute
Brooksville, Florida, 34613-6065
Arizona Eye Center
Chandler, Arizona, 85224
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, 45242
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, 16066-6412
Glaucoma Associates of Texas
Dallas, Texas, 75231-2168
Duke Eye Center
Durham, North Carolina, 27705
The Cataract and Glaucoma Center
El Paso, Texas, 79902
Eye Associates of Fort Myers
Fort Myers, Florida, 33901-9311
Global Research Management
Glendale, California, 91204-2569
Wake Forest Health Network Ophthamology - Oak Hollow
High Point, North Carolina, 27262-7612
Levenson Eye Associates
Jacksonville, Florida, 32204
Mayo Clinic, Dept. of Opthamology
Jacksonville, Florida, 32224
Bowden Eye & Associates
Jacksonville, Florida, 32258
Shettle Eye Research
Largo, Florida, 33773
Nevada Eye Care Professionals
Las Vegas, Nevada, 89119
AdvanceMed Clinical Research-Las Vegas
Las Vegas, Nevada, 89123-2810
Premiere Practice Management
Los Angeles, California, 90013
University Eye Specialists
Maryville, Tennessee, 37803-6100
VRF Eye Specialty Group
Memphis, Tennessee, 38120-9411
DCT- Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, 78572-2425
North Valley Eye Medical Group
Mission Hills, California, 91342
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
The Eye Research Foundation
Newport Beach, California, 92663-3642
University of California, Los Angeles, Doheny Eye Centers
Pasadena, California, 91105
North Bay Eye Associates, Inc
Petaluma, California, 94954
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701-7374
Rochester Ophthalmological Group, P.C.
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
Sacramento Eye Consultants
Sacramento, California, 95815-4605
Stacy R. Smith M.D. P.C.
Salt Lake City, Utah, 84117-5209
San Antonio Eye Center
San Antonio, Texas, 78215-1936
R and R Eye Research LLC
San Antonio, Texas, 78229-3539
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079-1855
Walman Eye Center
Sun City, Arizona, 85351-3019
Office of Mark J. Weiss MD
Tulsa, Oklahoma, 74104-5300
Vance Thompson Vision - ND
West Fargo, North Dakota, 58078
Clinical Eye Research of Boston, LLC
Winchester, Massachusetts, 01890

Other trials in United States

About this study

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

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.

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Being tested: DE-126 Ophthalmic Solution 0.002% QD, Timolol Maleate Ophthalmic Solution 0.5% BID
Keywords: Glaucoma
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DE-126 Ophthalmic Solution 0.002% QDDrug
DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
Timolol Maleate Ophthalmic Solution 0.5% BIDDrug
Timolol Maleate Ophthalmic Solution BID (morning and evening)

Study groups in NCT04742283
Study group	Role	What they receive
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD	Experimental	DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) Receives: Drug: DE-126 Ophthalmic Solution 0.002% QD
Timolol Maleate Opthalmic Solution 0.5% BID	Active comparator	Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) Receives: Drug: Timolol Maleate Ophthalmic Solution 0.5% BID

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Measured: 08:00, 10:00 and 16:00 at Week 2
Intraocular Pressure at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Measured: 08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure at Month 3
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Measured: 08:00, 10:00 and 16:00 at Month 3

Secondary outcomes (1)

Mean Diurnal Intraocular Pressure at Month 3
Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20207 Dec 2021

First posted8 Feb 2021
Study start17 Dec 2020
Primary completion7 Dec 2021
Study completion7 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04742283
Sponsor's protocol ID: 012604IN
Acronym: ANGEL-2
Status last verified: Jun 2023
First submitted: 28 Jan 2021
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wirta DL, El-Harazi SM, Tepedino ME, Bacharach J. Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: ANGEL-2. Ophthalmol Glaucoma. 2025 Jul-Aug;8(4):384-392. doi: 10.1016/j.ogla.2025.02.004. Epub 2025 Mar 4.
PubMed 40043909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04742283
Acronym / sponsor ID: ANGEL-2 / 012604IN
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: 17 Dec 2020 (actual)
Primary completion: 7 Dec 2021 (actual)
Study completion: 7 Dec 2021 (actual)
First posted: 8 Feb 2021 (actual)
Results: Posted 26 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD	Experimental	Drug: DE-126 Ophthalmic Solution 0.002% QDDE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
Timolol Maleate Opthalmic Solution 0.5% BID	Active comparator	Drug: Timolol Maleate Ophthalmic Solution 0.5% BIDTimolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DE-126 Ophthalmic Solution 0.002% QDDE-126 Ophthalmic Solution QD evening and Vehicle QD Morning	Drug	DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
Timolol Maleate Ophthalmic Solution 0.5% BIDTimolol Maleate Ophthalmic Solution BID (morning and evening)	Drug	Timolol Maleate Opthalmic Solution 0.5% BID

Primary outcome

Intraocular Pressure at Week 2
Time frame: 08:00, 10:00 and 16:00 at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Week 6
Time frame: 08:00, 10:00 and 16:00 at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Month 3
Time frame: 08:00, 10:00 and 16:00 at Month 3
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).

1 secondary outcome

Mean Diurnal Intraocular Pressure at Month 3
Time frame: Three months

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Timolol Maleate Opthalmic Solution 0.5% BID	161	148
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD	162	158

Primary outcome: Intraocular Pressure at Week 2

Time frame: 08:00, 10:00 and 16:00 at Week 2. Least squares mean (Standard Error). Unit: mmHg

Measure	Timolol Maleate Opthalmic Solution 0.5% BID n = 159	DE-126 Opthalmic Solution 0.002% QD and Vehicle QD n = 161
8:00	19.05 (0.242)	18.92 (0.239)
10:00	18.28 (0.219)	17.86 (0.216)
16:00	17.91 (0.215)	17.15 (0.212)

Population analysed: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.

Primary outcome: Intraocular Pressure at Week 6

Time frame: 08:00, 10:00 and 16:00 at Week 6. Least squares mean (Standard Error). Unit: mmHg

Measure	Timolol Maleate Opthalmic Solution 0.5% BID n = 159	DE-126 Opthalmic Solution 0.002% QD and Vehicle QD n = 161
8:00	18.72 (0.238)	18.32 (0.233)
10:00	18.29 (0.238)	17.96 (0.233)
16:00	18.24 (0.235)	17.52 (0.229)

Primary outcome: Intraocular Pressure at Month 3

Time frame: 08:00, 10:00 and 16:00 at Month 3. Least squares mean (Standard Error). Unit: mmHg

Measure	Timolol Maleate Opthalmic Solution 0.5% BID n = 159	DE-126 Opthalmic Solution 0.002% QD and Vehicle QD n = 161
8:00	18.78 (0.249)	18.80 (0.244)
10:00	18.12 (0.244)	18.07 (0.239)
16:00	18.52 (0.228)	17.57 (0.223)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Timolol Maleate Opthalmic Solution 0.5% BID	3 of 160 (1.9%)	34 of 160 (21.3%)	0 of 160
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD	1 of 161 (0.6%)	38 of 161 (23.6%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40043909Wirta DL, El-Harazi SM, Tepedino ME, Bacharach J. Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: ANGEL-2. Ophthalmol Glaucoma. 2025 Jul-Aug;8(4):384-392. doi: 10.1016/j.ogla.2025.02.004. Epub 2025 Mar 4.
Individual participant dataSharing planned: No

Related trials for Primary Open Angle Glaucoma

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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure at Week 2 (time frame: 08:00, 10:00 and 16:00 at Week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.