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Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

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ClinicalTrials.gov Identifier: NCT04445519
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
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. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: NCX 470 0.065% Drug: NCX 470 0.1% Drug: Latanoprost 0.005% Phase 3

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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: Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
Drug: NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065%
Other Name: NCX 470

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




Primary Outcome Measures :
  1. Reduction from baseline IOP in the study eye [ Time Frame: 3 months ]
    Mean IOP reduction 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. Reduction from baseline in diurnal IOP in the study eye [ Time Frame: 3 months ]
    Mean diurnal IOP reduction 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: 3 months ]
  3. Rate of discontinuation [ Time Frame: 3 months ]


Information from the National Library of Medicine

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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

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): NCT04445519


Contacts
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Contact: Sushanta Mallick, PhD 2148684744 mallick@nicox.com
Contact: Jose L Boyer, PhD 919-423-0747 boyer@nicox.com

Locations
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United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
Contact: Sushanta Mallick, PhD    214-868-4744    mallick@nicox.com   
Sponsors and Collaborators
Nicox Ophthalmics, Inc.
Investigators
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Study Director: Jose L Boyer, PhD Nicox Ophthalmics, Inc.
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Responsible Party: Nicox Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT04445519    
Other Study ID Numbers: NCX-470-02
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
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
Antihypertensive Agents