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Clinical Trials/NCT04630808
NCT04630808
Completed
Phase 3

A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

Nicox Ophthalmics, Inc.1 site in 1 country696 target enrollmentNovember 9, 2020
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ConditionsOpen Angle GlaucomaOcular Hypertension
InterventionsNCX 470 0.1%Latanoprost 0.005%
DrugsNCX 470 0.1%Latanoprost 0.005%

Overview

Phase
Phase 3
Intervention
NCX 470 0.1%
Conditions
Open Angle Glaucoma
Sponsor
Nicox Ophthalmics, Inc.
Enrollment
696
Locations
1
Primary Endpoint
Change from baseline IOP
Status
Completed
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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 subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.

Registry
clinicaltrials.gov
Start Date
November 9, 2020
End Date
June 25, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

NCX 470 0.1%

NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes

Intervention: NCX 470 0.1%

Latanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

Intervention: Latanoprost 0.005%

Outcomes

Primary Outcomes

Change from baseline IOP

Time Frame: Up to 3 months

Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye

Secondary Outcomes

  • Change from baseline in diurnal IOP(Up to 3 months)
  • Frequency and incidence of treatment-emergent adverse events(12 months)
  • Rate of discontinuation(12 months)

Study Sites (1)

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