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

• ClinicalTrials.gov Identifier: NCT04445519
• Recruitment Status: Completed
• First Posted: June 24, 2020
• Last Update Posted: October 24, 2022
• Sponsor: Nicox Ophthalmics, Inc.
• Information provided by (Responsible Party): Nicox Ophthalmics, Inc.

Study Description

Brief Summary:

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%.

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma; Ocular Hypertension	Drug: NCX 470 0.065% (initial phase of trial); Drug: Latanoprost 0.005% (initial phase of trial); Drug: NCX 470 0.1% (initial phase of trial); Drug: NCX 470 0.1% (remainder of trial); Drug: Latanoprost 0.005% (remainder of trial)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 670 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: double-masked
• Primary Purpose: Treatment
• Official Title: Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
• Actual Study Start Date: June 1, 2020
• Actual Primary Completion Date: September 16, 2022
• Actual Study Completion Date: September 16, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: NCX 470 0.065%; NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)	Drug: NCX 470 0.065% (initial phase of trial); NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
Experimental: NCX 470 0.1%; NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)	Drug: NCX 470 0.1% (initial phase of trial); NCX 470 Ophthalmic Solution, 0.1%
Active Comparator: Latanoprost 0.005%; Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)	Drug: Latanoprost 0.005% (initial phase of trial); Latanoprost Ophthalmic Solution, 0.005%; Other Name: Latanoprost
Experimental: 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)	Drug: NCX 470 0.1% (remainder of trial); NCX 470 Ophthalmic Solution, 0.1%
Active Comparator: Latanoprost 0.005% (remainder of trial); Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)	Drug: Latanoprost 0.005% (remainder of trial); Latanoprost Ophthalmic Solution, 0.005%

Outcome Measures

Primary Outcome Measures :

1. Reduction from baseline IOP in the study eye [ Time Frame: 3 months ]
   Mean IOP reduction from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye

Secondary Outcome Measures :

1. Reduction from baseline in diurnal IOP in the study eye [ Time Frame: 3 months ]
   Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
2. Frequency and incidence of treatment-emergent adverse events [ Time Frame: 3 months ]
3. Rate of discontinuation [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 84 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Eye Research Foundation

Newport Beach, California, United States, 92663

Sponsors and Collaborators

Nicox Ophthalmics, Inc.

Investigators

• Study Director: Doug Hubatsch; Nicox Ophthalmics, Inc.

More Information

• Responsible Party: Nicox Ophthalmics, Inc.
• ClinicalTrials.gov Identifier: NCT04445519
• Other Study ID Numbers: NCX-470-02
• First Posted: June 24, 2020
• Last Update Posted: October 24, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions