Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (Whistler)

January 9, 2024 updated by: Nicox Ophthalmics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Arthur Sit, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
NCX 470 0.1% vs Placebo
Other Names:
  • nitric oxide (NO)-donating bimatoprost prostaglandin analog
Placebo Comparator: Placebo
Artificial tears - one drop in the randomized eye once a day for 8 days
Drug: Placebo
NCX 0.1% vs Placebo
Other Names:
  • Artificial tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicox Ophthalmics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCX 470-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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