Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2025-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NCX 470 0.1%

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

Group Type ACTIVE_COMPARATOR

NCX 470

Intervention Type DRUG

NCX 470 0.1% vs Placebo

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NCX 0.1% vs Placebo

Interventions

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NCX 470

NCX 470 0.1% vs Placebo

Intervention Type DRUG

Placebo

NCX 0.1% vs Placebo

Intervention Type DRUG

Other Intervention Names

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nitric oxide (NO)-donating bimatoprost prostaglandin analog Artificial tears

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes