Whistler: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Sponsor

Nicox Ophthalmics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05938699

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Drug: NCX 470 Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in AHD [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

≥18 years of age
Either gender
Subjects without glaucoma
Intraocular pressure between 16 and 28 mmHg

Exclusion Criteria:

Subjects with narrow angles
Subjects with a CCT less than 480 µm or greater than 620 µm in either eye
Chronic or recurrent inflammatory eye disease, infection or trauma in either eye.
Clinically significant retinal disease
Severe dry eye in either eye
Serious hypersensitivity to topical anesthetic eye drops
Subjects with uncontrolled chronic diseases (e.g., uncontrolled hypertension/diabetes)
Using medications that are known to affect IOP, EVP, and aqueous flow rate
Using marijuana or marijuana derivatives
Subjects with known contraindications to NO treatments (e.g., alcohol abuse)
Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications