What side effects are associated with this type of intervention?

Common treatments for Open-Angle Glaucoma that enhance aqueous humor outflow, such as prostaglandin analogs, can cause side effects including eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to systemic effects like bradycardia and respiratory issues. Alpha agonists can cause dry mouth, fatigue, and allergic reactions. Carbonic anhydrase inhibitors might result in a metallic taste, frequent urination, and tingling in fingers and toes. Rho kinase inhibitors are associated with eye redness and discomfort. It is important to discuss these potential side effects with your doctor to determine the best treatment option for you.

What prior FDA approvals exist?

Several FDA-approved treatments for Open-Angle Glaucoma work by lowering intraocular pressure through enhanced aqueous humor outflow. Prostaglandin analogs such as latanoprost, bimatoprost, and travoprost increase uveoscleral outflow. Rho kinase inhibitors like netarsudil improve trabecular meshwork outflow. Additionally, combination drugs like latanoprostene bunod, which combines a prostaglandin analog with a nitric oxide-donating moiety, also enhance aqueous humor outflow. These treatments are similar to NCX 470, which is being studied for its potential to lower IOP by enhancing aqueous humor dynamics.

What other types of research exist?

Promising novel alternatives to NCX 470 for open-angle glaucoma patients include: 1) Rho kinase inhibitors, which target the trabecular meshwork/Schlemm canal to reduce outflow resistance. 2) Nitric oxide donating compounds, such as NCX 667, which have shown robust IOP-lowering effects in animal models by enhancing outflow. These alternatives are complementary to existing therapies and have obtained recent FDA approval.

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NCX 470 for Glaucoma (Whistler Trial)

Phase 2 & 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

Subjects without glaucoma

≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 days

Summary

This trial uses an eye drop solution called NCX 470, a nitric oxide (NO)-donating bimatoprost, to study its effects on eye fluid movement in healthy individuals and those with high eye pressure.

Who is the study for?

This trial is for adults over 18 years old, of any gender, who do not have glaucoma but may have ocular hypertension (OHT) with eye pressure between 16 and 28 mmHg. It's not suitable for people already diagnosed with glaucoma.

What is being tested?

The study tests NCX 470 ophthalmic solution against a placebo to see how it affects the fluid dynamics in the eyes of healthy volunteers or those with high eye pressure but no glaucoma.

What are the potential side effects?

While specific side effects are not listed here, typical reactions to ophthalmic solutions can include temporary burning sensation, eye irritation or discomfort, watery eyes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I do not have glaucoma.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days 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 in AHD

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NCX 470 0.1%Active Control1 Intervention

NCX 470 0.1% - one drop in the randomized eye once a day for 8 days

Group II: PlaceboPlacebo Group1 Intervention

Artificial tears - one drop in the randomized eye once a day for 8 days

0 / 2Eligibility 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 Open-Angle Glaucoma primarily aim to lower intraocular pressure (IOP), which is critical for preventing optic nerve damage and preserving vision. Treatments like NCX 470 ophthalmic solution work by enhancing the outflow of aqueous humor, thereby reducing IOP. Other common treatments include prostaglandin analogs, which increase uveoscleral outflow, and beta-blockers, which reduce aqueous humor production. Additionally, alpha agonists and carbonic anhydrase inhibitors also decrease aqueous humor production. These mechanisms are vital for Open-Angle Glaucoma patients as they help manage IOP, slowing disease progression and preventing vision loss.