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
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

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