Glaucoma Open-Angle PrimaryPhase 2NCT05913232

Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 2 study testing H-1337 0.6%, H-1337 1.0% and Timolol 0.5% in people with Glaucoma Open-Angle Primary and Ocular Hypertension, run by D. Western Therapeutics Institute, Inc. at 9 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

The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 [0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma Open-Angle Primary, Ocular Hypertension
What is being tested?: H-1337 0.6%, H-1337 1.0% and Timolol 0.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: 9 sitesUnited States
Study dates: 28 Aug 2023to 29 Aug 2024
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

Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Who cannot join

Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye
Note: Other inclusion/exclusion criteria apply.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Dixon Eye Care
Albany, Georgia, 31701
Skyline Vision Clinic and Laser Center
Colorado Springs, Colorado, 80907
Global Research Management
Glendale, California, 91204
Central Florida Eye Associates
Lakeland, Florida, 33805
Shettle Eye Research, Inc.
Largo, Florida, 33773
University Eye Specialists
Maryville, Tennessee, 37803
Vistar Eye Center
Roanoke, Virginia, 24011
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076

Other trials in United States

About this study

Official title: A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension

Conditions: Glaucoma Open-Angle Primary, Ocular Hypertension
Being tested: H-1337 0.6%, H-1337 1.0%, H-1337 Placebo, Timolol 0.5%
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

H-1337 0.6%Drug
ophthalmic solution
H-1337 1.0%Drug
ophthalmic solution
H-1337 PlaceboDrug
ophthalmic solution
Timolol 0.5%Drug
ophthalmic solution

Study groups in NCT05913232
Study group	Role	What they receive
H-1337 0.6% Ophthalmic Solution b.i.d.	Experimental	One drop H-1337 twice daily in the study eye for 28 days Receives: Drug: H-1337 0.6%
H-1337 1.0% Ophthalmic Solution b.i.d.	Experimental	One drop H-1337 twice daily in the study eye for 28 days Receives: Drug: H-1337 1.0%
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	Experimental	One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days Receives: Drug: H-1337 1.0%; Drug: H-1337 Placebo
Timolol 0.5% Ophthalmic Solution b.i.d.	Active comparator	One drop Timolol twice daily in the study eye for 28 days Receives: Drug: Timolol 0.5%

What is being measured

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

Efficacy as Assessed by Change in Intraocular Pressure
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
Measured: Day 28

Secondary outcomes (2)

Efficacy as Assessed by Intraocular Pressure
Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Measured: Day 0, Day 1, Day 7, Day 14, and Day 28
Safety as Assessed by Adverse Event Reporting
Percentage of participants with ocular and systemic adverse events
Measured: Screening through Day 28

Timeline

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

28 Aug 202329 Aug 2024

First posted22 Jun 2023
Study start28 Aug 2023
Primary completion29 Aug 2024
Study completion29 Aug 2024

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.
Other trials for Glaucoma Open-Angle PrimaryStudies 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: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05913232
Sponsor's protocol ID: H1337-CS202
Status last verified: Aug 2025
First submitted: 12 Jun 2023
Last updated: 27 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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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Recruiting
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All Glaucoma Open-Angle Primary trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension
ClinicalTrials.gov ID: NCT05913232
Acronym / sponsor ID: H1337-CS202
Conditions: Glaucoma Open-Angle Primary, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: D. Western Therapeutics Institute, Inc.Industry (pharma, biotech, devices)
Study start: 28 Aug 2023 (actual)
Primary completion: 29 Aug 2024 (actual)
Study completion: 29 Aug 2024 (actual)
First posted: 22 Jun 2023 (actual)
Results: Posted 27 Aug 2025

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: 4

Arm	Type	Receives
H-1337 0.6% Ophthalmic Solution b.i.d.	Experimental	Drug: H-1337 0.6%One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0% Ophthalmic Solution b.i.d.	Experimental	Drug: H-1337 1.0%One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	Experimental	Drug: H-1337 1.0%, Drug: H-1337 PlaceboOne drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
Timolol 0.5% Ophthalmic Solution b.i.d.	Active comparator	Drug: Timolol 0.5%One drop Timolol twice daily in the study eye for 28 days

Who may qualify

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

Key inclusion criteria (1 listed)

Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Key exclusion criteria (2 listed)

Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye
Note: Other inclusion/exclusion criteria apply.

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
H-1337 0.6%ophthalmic solution	Drug	H-1337 0.6% Ophthalmic Solution b.i.d.
H-1337 1.0%ophthalmic solution	Drug	H-1337 1.0% Ophthalmic Solution b.i.d., H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
H-1337 Placeboophthalmic solution	Drug	H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
Timolol 0.5%ophthalmic solution	Drug	Timolol 0.5% Ophthalmic Solution b.i.d.

Primary outcome

Efficacy as Assessed by Change in Intraocular Pressure
Time frame: Day 28
Mean change in intraocular pressure from baseline on Day 28 compared to timolol

2 secondary outcomes

Efficacy as Assessed by Intraocular Pressure
Time frame: Day 0, Day 1, Day 7, Day 14, and Day 28
Safety as Assessed by Adverse Event Reporting
Time frame: Screening through Day 28

Results and safety

Results posted to the registry on 27 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
H-1337 0.6% Ophthalmic Solution b.i.d.	51	51
H-1337 1.0% Ophthalmic Solution b.i.d.	51	49
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	50	49
Timolol 0.5% Ophthalmic Solution b.i.d.	49	48

Primary outcome: Efficacy as Assessed by Change in Intraocular Pressure

Time frame: Day 28. Mean (Standard Deviation). Unit: mmHg

Measure	H-1337 0.6% Ophthalmic Solution b.i.d. n = 51	H-1337 1.0% Ophthalmic Solution b.i.d. n = 51	H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. n = 50	Timolol 0.5% Ophthalmic Solution b.i.d. n = 49
Day 28: Pre T0, change from baseline (mmHg)	-6.3 (3.27)	-6.3 (3.15)	-5.9 (3.45)	-7.0 (3.26)
Day 28: T0 + 2h, change from baseline (mmHg)	-7.3 (3.07)	-7.2 (3.14)	-6.5 (3.67)	-6.3 (3.83)
Day 28: T0 + 4h, change from baseline (mmHg)	-7.5 (3.28)	-7.3 (3.24)	-6.8 (3.48)	-5.3 (3.53)
Day 28: T0 + 8h, change from baseline (mmHg)	-6.8 (3.67)	-6.5 (3.50)	-6.1 (3.12)	-5.3 (3.21)
Day 28: T0 + 12h, change from baseline (mmHg)	-5.6 (3.82)	-5.3 (3.37)	-5.5 (3.44)	-4.9 (3.35)
Day 28: 8-hour diurnal, change from baseline (mmHg)	-7.2 (3.04)	-7.0 (2.90)	-6.4 (3.14)	-5.6 (3.16)
Day 28: 12-hour diurnal, change from baseline (mmHg)	-6.8 (3.02)	-6.6 (2.76)	-6.2 (3.11)	-5.4 (2.99)

Population analysed: Intent-to-Treat (ITT) is defined as all randomized subjects.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
H-1337 0.6% Ophthalmic Solution b.i.d.	0 of 51 (0%)	19 of 51 (37.3%)	0 of 51
H-1337 1.0% Ophthalmic Solution b.i.d.	0 of 51 (0%)	28 of 51 (54.9%)	0 of 51
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	0 of 50 (0%)	29 of 50 (58%)	0 of 50
Timolol 0.5% Ophthalmic Solution b.i.d.	0 of 49 (0%)	8 of 49 (16.3%)	0 of 49

Limitations and caveats (from the sponsor): No significant limitations or caveats were reported for the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

El-Roy Dixon, MD principal investigator

Dixon Eye Care

9 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 1 inclusion and 2 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 27 Aug 2025). 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?

Efficacy as Assessed by Change in Intraocular Pressure (time frame: Day 28). 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 NCT05913232.

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 27 Aug 2025.