Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Nicox Ophthalmics, Inc.18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Open Angle Glaucoma

Interventions

NCX 470DRUG

NCX 470 0.1% vs Placebo

PlaceboDRUG

NCX 0.1% vs Placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 days

Data from ClinicalTrials.gov

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