What is the mechanism of action of this treatment?

Timolol Maleate, a beta-adrenergic receptor blocker, reduces intraocular pressure (IOP) by decreasing the production of aqueous humor in the eye. This is essential for patients with ocular hypertension as elevated IOP is a significant risk factor for glaucoma, potentially leading to vision loss. Other common treatments include prostaglandin analogs, which enhance aqueous humor outflow, and carbonic anhydrase inhibitors, which similarly reduce its production. These mechanisms are vital for effectively managing IOP and preventing the progression to glaucoma.

What side effects are associated with this type of intervention?

Common treatments for ocular hypertension, such as Timolol Maleate, can cause side effects including eye irritation, burning or stinging upon application, dry eyes, and blurred vision. Systemic side effects may include bradycardia, hypotension, bronchospasm, and fatigue. Novel compounds like H-1337, while not specifically detailed, may have similar ocular and systemic side effects, including local irritation and potential systemic absorption effects.

What prior FDA approvals exist?

FDA-approved treatments for ocular hypertension include Timolol Maleate, a beta-adrenergic receptor blocker that reduces intraocular pressure. Other similar treatments are prostaglandin analogs like latanoprost, carbonic anhydrase inhibitors like dorzolamide, and alpha agonists such as brimonidine. These drugs work by either increasing the outflow or decreasing the production of aqueous humor to lower intraocular pressure.

What other types of research exist?

Promising novel alternatives for ocular hypertension treatment in 2024 include: <ol> <li>Rho kinase inhibitors (e.g., Netarsudil) - These drugs increase aqueous humor outflow through the trabecular meshwork.</li> <li></li> </ol> Prostaglandin analogs (e.g., Latanoprostene bunod) - These enhance uveoscleral outflow and trabecular meshwork outflow. 3. Nitric oxide-donating prostaglandin analogs (e.g., Vyzulta) - These combine the effects of prostaglandin analogs with nitric oxide to improve outflow. 4. Adenosine receptor agonists (e.g., Trabodenoson) - These increase trabecular meshwork outflow. 5. Novel drug delivery systems (e.g., sustained-release implants) - These provide consistent drug delivery and improve adherence.

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Prostaglandin Analog

H-1337 for Glaucoma

Phase 2

Waitlist Available

Led By El-Roy Dixon, MD

Research Sponsored by D. Western Therapeutics Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Summary

This trial is testing different doses of a new eye drop (H-1337) in patients who need treatment in both eyes. The goal is to see if H-1337 is safe and effective. Both treatments work by reducing pressure inside the eyes. The existing treatment has been used for many years but has some issues with how well it works and how easy it is for patients to use.

Who is the study for?

This trial is for people with primary open angle glaucoma or ocular hypertension in both eyes. Participants must not have closed or very narrow angles in their eyes, as judged by an eye exam within the last 6 months.

What is being tested?

The study tests three doses of H-1337 (0.6% twice daily, 1.0% twice daily, and 1.0% once a day) against Timolol (0.5%, twice daily). Each treatment will be given in both eyes for four weeks to see which is safer and more effective.

What are the potential side effects?

Possible side effects may include discomfort in the eyes, redness, blurred vision, dryness or tearing up more than usual. Since it's a study drug, there might be unknown risks that will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with glaucoma or high eye pressure in both eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as Assessed by Change in Intraocular Pressure

Secondary study objectives

Efficacy as Assessed by Intraocular Pressure

Safety as Assessed by Adverse Event Reporting

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.Experimental Treatment2 Interventions

One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days

Group II: H-1337 1.0% Ophthalmic Solution b.i.d.Experimental Treatment1 Intervention

One drop H-1337 twice daily in the study eye for 28 days

Group III: H-1337 0.6% Ophthalmic Solution b.i.d.Experimental Treatment1 Intervention

One drop H-1337 twice daily in the study eye for 28 days

Group IV: Timolol 0.5% Ophthalmic Solution b.i.d.Active Control1 Intervention

One drop Timolol twice daily in the study eye for 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

H-1337 0.6%

2023

Completed Phase 2

~210

H-1337 Placebo

2023

Completed Phase 2

~290

H-1337 1.0%

2023

Completed Phase 2

~220

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Timolol Maleate, a beta-adrenergic receptor blocker, reduces intraocular pressure (IOP) by decreasing the production of aqueous humor in the eye. This is essential for patients with ocular hypertension as elevated IOP is a significant risk factor for glaucoma, potentially leading to vision loss. Other common treatments include prostaglandin analogs, which enhance aqueous humor outflow, and carbonic anhydrase inhibitors, which similarly reduce its production. These mechanisms are vital for effectively managing IOP and preventing the progression to glaucoma.

Effects of topical administration of timolol maleate on intraocular pressure and pupil size in dogs.Ciliary vasoconstriction after topical adrenergic drugs.The effects of separate and combined topical treatment with timolol maleate and trifluormethazolamide on the intraocular pressure in normal rabbits.