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

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle; Hypertension, Ocular
• Interventions: Drug: NCX 470; Drug: Latanoprost 0.005%

• Registration Number: NCT03657797
• Lead Sponsor: Nicox Ophthalmics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-23
• Disposition First Submitted: 2020-09-18
• Disposition First Submitted QC: 2020-09-18
• Disposition First Posted: 2020-09-24
• Results First Submitted: 2022-11-09
• Results First Submitted QC: 2022-11-09
• Results First Posted: 2022-12-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 656

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCX 470 0.021%	NCX 470	NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks
NCX 470 0.042%	NCX 470	NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks
NCX 470 0.065%	NCX 470	NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks
Latanoprost 0.005%	Latanoprost 0.005%	Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit	Baseline, week 1, week 2, 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)
Percentage of Subjects With Treatment-emergent Ocular Adverse Events	4 weeks for adverse events and through 30 days post-treatment for serious adverse events	Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events

Trial Locations

Locations (1)

Texan Eye; 🇺🇸 Austin, Texas, United States