What side effects are associated with this type of intervention?

Common treatments for ocular hypertension that increase aqueous humor outflow, such as prostaglandin analogs (e.g., latanoprost), can have several side effects. These may include eye redness, eyelash growth, changes in iris color, and eye discomfort. Less commonly, they can cause systemic effects like respiratory issues or muscle pain. It is important for patients to discuss these potential side effects with their doctor to determine the best treatment plan.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of ocular hypertension by increasing aqueous humor outflow. Latanoprost, a prostaglandin analog, is one of the most commonly used medications and works by increasing the outflow of aqueous humor through the uveoscleral pathway. Other prostaglandin analogs include bimatoprost and travoprost. Additionally, medications like timolol, a beta-blocker, and brimonidine, an alpha agonist, are also used, although they primarily reduce aqueous humor production rather than increasing outflow. These treatments are similar in their goal to lower intraocular pressure, which is crucial in managing ocular hypertension and preventing glaucoma.

What other types of research exist?

Promising alternatives to NCX 470 for ocular hypertension include latanoprost, a well-established prostaglandin analog, and newer agents like netarsudil, which increases aqueous humor outflow through the trabecular meshwork. Additionally, combination therapies such as latanoprostene bunod, which combines a prostaglandin analog with a nitric oxide-donating moiety, are also being explored for their enhanced efficacy in lowering IOP.

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Prostaglandin Analog

NCX 470 for Glaucoma (Denali Trial)

Phase 3

Recruiting

Research Sponsored by Nicox Ophthalmics, Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of open-angle glaucoma or ocular hypertension in both eyes

Be older than 18 years old

Must not have

Previous complicated surgery or certain types of glaucoma surgery in either eye

Uncontrolled systemic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing NCX 470 eye drops to see if they can safely and effectively lower eye pressure in people with high eye pressure or glaucoma. The goal is to protect their vision by reducing the pressure inside their eyes. NCX 470 is a nitric oxide (NO)-donating bimatoprost with clinically demonstrated pressure-lowering effects.

Who is the study for?

This trial is for people who can consent to participate and have open-angle glaucoma or ocular hypertension in both eyes. They must show qualifying eye pressure at different times of the day and have good corrected vision in each eye. Those with recent serious eye surgery, uncontrolled diseases, significant other eye conditions, narrow chamber angles or unsuitable corneal thickness cannot join.

What is being tested?

The study tests NCX 470 Ophthalmic Solution against Latanoprost to see which is better at lowering intraocular pressure in patients with high eye pressure or open-angle glaucoma. Participants will be randomly assigned to one of these treatments and use it daily for up to a year.

What are the potential side effects?

Possible side effects may include local irritation, redness, discomfort in the eyes, changes in eyelash growth or pigmentation around the eyes. Systemic side effects are rare but could potentially affect breathing or heart rate.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had complex or specific glaucoma surgery in either eye.

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I have a disease that is not currently under control.

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I have a serious eye condition.

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My eye's front chamber is narrow or my cornea is too thin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline IOP

Secondary study objectives

Change from baseline in diurnal IOP

Frequency and incidence of treatment-emergent adverse events

Rate of discontinuation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NCX 470 0.1%Experimental Treatment1 Intervention

NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes

Group II: Latanoprost 0.005%Active Control1 Intervention

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

0 / 5Eligibility 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

The most common treatments for ocular hypertension aim to lower intraocular pressure (IOP) by either increasing the outflow or decreasing the production of aqueous humor. Prostaglandin analogs, like latanoprost, and newer agents like NCX 470, work by increasing the outflow of aqueous humor through the uveoscleral pathway, thereby reducing IOP. Beta-blockers, such as timolol, decrease aqueous humor production by inhibiting beta-adrenergic receptors in the ciliary body. Carbonic anhydrase inhibitors reduce IOP by decreasing aqueous humor secretion through the inhibition of carbonic anhydrase enzyme. Alpha agonists both decrease aqueous humor production and increase uveoscleral outflow. Understanding these mechanisms is crucial for patients as effective management of IOP can prevent the progression to glaucoma and preserve vision.