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

Nicox Ophthalmics, Inc.691 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

691

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3

The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.

Time frame: Baseline, Week 2, Week 6, and Month 3

Secondary Outcomes

Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye

Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis. Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months. Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).

Time frame: Baseline, Week 2, Week 6, and Month 3

Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population

Safety and tolerability based on number subjects with treatment emergent ocular adverse events.

Time frame: 3 months

Rate of Discontinuation

Number of subjects discontinued from the study.