Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

NCT05938699 | Completed Phase 2 FDA Drug

• 1 other identifier: NCX 470-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.

Conditions

Open Angle Glaucoma

Keywords

glaucoma; NCX 470; nitric oxide; prostaglandin analogue

Outcome Measures

Primary Outcomes (1)

• Change in AHD

  The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo.

  8 days

Study Arms (2)

NCX 470 0.1%

ACTIVE COMPARATOR

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

Drug: NCX 470

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NCX 470 DRUG

NCX 470 0.1% vs Placebo

Also known as: nitric oxide (NO)-donating bimatoprost prostaglandin analog

NCX 470 0.1%

Placebo DRUG

NCX 0.1% vs Placebo

Also known as: Artificial tears

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Either gender
• Subjects without glaucoma
• Qualifying IOP at Screening Visit

You may not qualify if:

• Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
• Clinically significant ocular disease in either eye
• Uncontrolled systemic disease
• Serious hypersensitivity to topical anesthetic eye drops
• Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications

Sponsors & Collaborators

• Nicox Ophthalmics, Inc.: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Nitric Oxide; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 10, 2023
• Study Start: December 12, 2023
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)