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OpenTrials
Completed

NCT Number: NCT05938699

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

NCX 470

Drug

NCX 470 0.1% vs Placebo

Other names: nitric oxide (NO)-donating bimatoprost prostaglandin analog

Placebo

Drug

NCX 0.1% vs Placebo

Other names: Artificial tears

Primary outcomes

  1. Change in AHD

    Time frame: 8 days

    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.

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study title

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)

Acronym: Whistler

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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