Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Nicox Ophthalmics, Inc.656 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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

656

Conditions

Glaucoma, Open-Angle Hypertension, Ocular

Interventions

NCX 470DRUG

NCX 470 Ophthalmic Solution

Latanoprost 0.005%DRUG

Latanoprost 0.005% Ophthalmic Solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of open-angle glaucoma or ocular hypertension in both eyes * Qualifying IOP at 3 time points throughout the day at 2 visits following washout of IOP-lowering medication, if applicable * Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye * Ability to provide informed consent and follow study instructions Exclusion Criteria: * Pigmentary or pseudoexfoliative glaucoma * 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

Locations (1)

Texan Eye

Austin, Texas, United States

Outcomes

Primary Outcomes

Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4

Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4.

Time frame: Baseline, Week 4

Secondary Outcomes

Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit

Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. One eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit)

Time frame: Baseline, week 1, week 2, exit visit

Percentage of Subjects With Treatment-emergent Ocular Adverse Events

Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events

Time frame: 4 weeks for adverse events and through 30 days post-treatment for serious adverse events

Data from ClinicalTrials.gov

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