Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-08-23

Brief Summary

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The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

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Detailed Description

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Conditions

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Glaucoma, Open-Angle Hypertension, Ocular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NCX 470 0.021%

NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks

Group Type EXPERIMENTAL

NCX 470

Intervention Type DRUG

NCX 470 Ophthalmic Solution

NCX 470 0.042%

NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks

Group Type EXPERIMENTAL

NCX 470

Intervention Type DRUG

NCX 470 Ophthalmic Solution

NCX 470 0.065%

NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks

Group Type EXPERIMENTAL

NCX 470

Intervention Type DRUG

NCX 470 Ophthalmic Solution

Latanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005%

Intervention Type DRUG

Latanoprost 0.005% Ophthalmic Solution

Interventions

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NCX 470

NCX 470 Ophthalmic Solution

Intervention Type DRUG

Latanoprost 0.005%

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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Latanoprost

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOP at 3 time points throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
* Ability to provide informed consent and follow study instructions

Exclusion Criteria

* Pigmentary or pseudoexfoliative glaucoma
* Narrow anterior chamber angles or disqualifying corneal thickness in either eye
* Clinically significant ocular disease in either eye
* Previous complicated surgery or certain types of glaucoma surgery in either eye
* Incisional ocular surgery or severe trauma in either eye within the past 6 months
* Uncontrolled systemic disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No