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

Ocular Hypertension Clinical Trial

— Mont Blanc  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445519
• Other study ID #: NCX-470-02
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: September 16, 2022

Study information

• Verified date: June 2023
• Source: Nicox Ophthalmics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• NCX 470 0.065% (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
• Latanoprost 0.005% (initial phase of trial)
Latanoprost Ophthalmic Solution, 0.005%
• NCX 470 0.1% (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.1%
• NCX 470 0.1% (remainder of trial)
NCX 470 Ophthalmic Solution, 0.1%
• Latanoprost 0.005% (remainder of trial)
Latanoprost Ophthalmic Solution, 0.005%

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Nicox Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction from baseline IOP in the study eye	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	3 months
Secondary	Reduction from baseline in diurnal IOP in the study eye	Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye	3 months
Secondary	Frequency and incidence of treatment-emergent adverse events		3 months
Secondary	Rate of discontinuation		3 months