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

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657797
• Other study ID #: NCX-470-17001
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: August 23, 2019

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 656
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• NCX 470
NCX 470 Ophthalmic Solution
• Latanoprost 0.005%
Latanoprost 0.005% Ophthalmic Solution

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas

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	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	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
Secondary	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