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NCT05938699 Clinical Trial

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Open Angle Glaucoma Clinical Trial

— Whistler  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05938699
Other study ID # NCX 470-05
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 12, 2023
Est. completion date March 31, 2025

Study information
Verified date January 2024
Source Nicox Ophthalmics, Inc.
Contact Siobhan Garbutt, PhD
Phone 984-710-5354
Email NCX470@nicox.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• NCX 470
NCX 470 0.1% vs Placebo
• Placebo
NCX 0.1% vs Placebo

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Nicox Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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