MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

NicOx

Status and phase: Enrolling; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost 0.005%; Drug: NCX 470 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04630808

NCX-470-03

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 subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.

Enrollment: 670 estimated 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 2 patient groups

NCX 470 0.1%

Experimental group

Description:

NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes

Treatment:

Drug: NCX 470 0.1%

Latanoprost 0.005%

Active Comparator group

Description:

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

Treatment:

Drug: Latanoprost 0.005%