ClinicalTrials.gg
CompletedNCT05938699WhistlerUpdated Sep 8, 2025

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

A Phase 2/3 interventional study of NCX 470 and Placebo in Open Angle Glaucoma, sponsored by Nicox Ophthalmics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Nicox Ophthalmics, Inc. · Phase 2/3, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Mar 2025, 1 year 7 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Sep 2025.
Phase
Phase 2/3
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Open Angle Glaucoma

Keywords

  • glaucoma
  • NCX 470
  • nitric oxide
  • prostaglandin analogue
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 18 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Nicox Ophthalmics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥18 years of age
  2. Either gender
  3. Subjects without glaucoma
  4. Qualifying IOP at Screening Visit

Exclusion criteria

Exclusion Criteria:

  1. Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
  2. ocular disease in either eye
  3. Uncontrolled systemic disease
  4. Serious to topical anesthetic eye drops
  5. Subjects with a known hypersensitivity or to any of the ingredients in the study medications
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    NCX 470 0.1%

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

    Drug: NCX 470

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • NCX 470 0.1% vs Placebo

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

  • DrugPlacebo

    NCX 0.1% vs Placebo

    Also known as: Artificial tears

06

What researchers measure

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.

    Time frame: 8 days

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938699
Lead sponsor
Nicox Ophthalmics, Inc.
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Dec 12, 2023
Primary completion
Mar 17, 2025
Completion
Mar 17, 2025
Last update
Sep 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NCX 470

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