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

A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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 Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Hypertension, Ocular
• Intervention / Treatment: Drug: NCX 470; Drug: Latanoprost 0.005%

• Study Type: Interventional
• Enrollment (Actual): 656
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NCX 470 0.021%; NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks	Drug: NCX 470; NCX 470 Ophthalmic Solution
Experimental: NCX 470 0.042%; NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks	Drug: NCX 470; NCX 470 Ophthalmic Solution
Experimental: NCX 470 0.065%; NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks	Drug: NCX 470; NCX 470 Ophthalmic Solution
Active Comparator: Latanoprost 0.005%; Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks	Drug: Latanoprost 0.005%; Latanoprost 0.005% Ophthalmic Solution; Other Names: Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	4 weeks for adverse events and through 30 days post-treatment for serious adverse events

Collaborators and Investigators

• Sponsor: Nicox Ophthalmics, Inc.
• Investigators: Study Director: Nicox Ophthalmics, Inc., Nicox Ophthalmics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: NCX-470-17001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No