Phase 3 Trial 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

PHASE3

Total Enrollment

691 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-09-16

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. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.

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Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-masked

Study Groups

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NCX 470 0.065%

NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)

Group Type EXPERIMENTAL

NCX 470 0.065% (initial phase of trial)

Intervention Type DRUG

NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)

NCX 470 0.1%

NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)

Group Type EXPERIMENTAL

NCX 470 0.1% (initial phase of trial)

Intervention Type DRUG

NCX 470 Ophthalmic Solution, 0.1%

Latanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% (initial phase of trial)

Intervention Type DRUG

Latanoprost Ophthalmic Solution, 0.005%

NCX 470 0.1% (remainder of trial)

NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)

Group Type EXPERIMENTAL

NCX 470 0.1% (remainder of trial)

Intervention Type DRUG

NCX 470 Ophthalmic Solution, 0.1%

Latanoprost 0.005% (remainder of trial)

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% (remainder of trial)

Intervention Type DRUG

Latanoprost Ophthalmic Solution, 0.005%

Interventions

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NCX 470 0.065% (initial phase of trial)

NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)

Intervention Type DRUG

Latanoprost 0.005% (initial phase of trial)

Latanoprost Ophthalmic Solution, 0.005%

Intervention Type DRUG

NCX 470 0.1% (initial phase of trial)

NCX 470 Ophthalmic Solution, 0.1%

Intervention Type DRUG

NCX 470 0.1% (remainder of trial)

NCX 470 Ophthalmic Solution, 0.1%

Intervention Type DRUG

Latanoprost 0.005% (remainder of trial)

Latanoprost Ophthalmic Solution, 0.005%

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 through the day at 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity in each eye
* Ability to provide informed consent and follow study instructions

Exclusion Criteria

* 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

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No