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Trial record 1 of 1 for:    NCT04630808
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MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

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ClinicalTrials.gov Identifier: NCT04630808
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Nicox Ophthalmics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: NCX 470 0.1% Drug: Latanoprost 0.005% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-masked
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
 Drug: NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1%
Other Name: NCX 470
Active Comparator: Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
 Drug: Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005%
Other Name: Latanoprost


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in diurnal IOP [ Time Frame: Up to 3 months ]
    Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye

  2. Frequency and incidence of treatment-emergent adverse events [ Time Frame: 12 months ]
    Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events

  3. Rate of discontinuation [ Time Frame: 12 months ]
    Percentage of subjects in each treatment group who discontinue study participation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630808


Contacts
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Contact: Doug Hubatsch 832-360-3022 hubatsch@nicox.com
Contact: Siobhan Garbutt, PhD 630-525-0376 garbutt@nicox.com

Locations
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United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
Contact: Linda Wirta    949-650-1863      
Sponsors and Collaborators
Nicox Ophthalmics, Inc.
Investigators
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Study Director: Doug Hubatsch Nicox Ophthalmics, Inc.
More Information
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Responsible Party: Nicox Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT04630808    
Other Study ID Numbers: NCX-470-03
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions