search
Back to results

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (Whistler)

Primary Purpose

Open Angle Glaucoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NCX 470
Placebo
Sponsored by
Nicox Ophthalmics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Open Angle Glaucoma focused on measuring glaucoma, NCX 470, nitric oxide, prostaglandin analogue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    NCX 470 0.1%

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Nicox Ophthalmics, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05938699
    Brief Title
    Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution
    Acronym
    Whistler
    Official Title
    Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nicox Ophthalmics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open Angle Glaucoma
    Keywords
    glaucoma, NCX 470, nitric oxide, prostaglandin analogue

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NCX 470 0.1%
    Arm Type
    Active Comparator
    Arm Description
    NCX 470 0.1% - one drop in the randomized eye once a day for 8 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Artificial tears - one drop in the randomized eye once a day for 8 days
    Intervention Type
    Drug
    Intervention Name(s)
    NCX 470
    Other Intervention Name(s)
    nitric oxide (NO)-donating bimatoprost prostaglandin analog
    Intervention Description
    NCX 470 0.1% vs Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Artificial tears
    Intervention Description
    NCX 0.1% vs Placebo
    Primary Outcome Measure Information:
    Title
    Change in AHD
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siobhan Garbutt, PhD
    Phone
    984-710-5354
    Email
    NCX470@nicox.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

    We'll reach out to this number within 24 hrs