Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

NicOx

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost 0.005% (remainder of trial); Drug: NCX 470 0.1% (remainder of trial); Drug: NCX 470 0.065% (initial phase of trial); Drug: NCX 470 0.1% (initial phase of trial); Drug: Latanoprost 0.005% (initial phase of trial)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04445519

NCX-470-02

Details and patient eligibility

About

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%.

Enrollment: 670 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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670 participants in 5 patient groups

NCX 470 0.065%

Experimental group

Description:

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

Treatment:

Drug: NCX 470 0.065% (initial phase of trial)

NCX 470 0.1%

Experimental group

Description:

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

Treatment:

Drug: NCX 470 0.1% (initial phase of trial)

Latanoprost 0.005%

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost 0.005% (initial phase of trial)

NCX 470 0.1% (remainder of trial)

Experimental group

Description:

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

Treatment:

Drug: NCX 470 0.1% (remainder of trial)

Latanoprost 0.005% (remainder of trial)

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost 0.005% (remainder of trial)