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Denali: MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Sponsor
Nicox Ophthalmics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04630808
Collaborator
(none)
670
Enrollment
1
Location
2
Arms
25.7
Anticipated Duration (Months)
26
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: NCX 470 0.1%
  • Drug: Latanoprost 0.005%
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 9, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Latanoprost

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline IOP [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 [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 [12 months]

      Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events

    3. Rate of discontinuation [12 months]

      Percentage of subjects in each treatment group who discontinue study participation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Eye Research Foundation Newport Beach California United States 92663

    Sponsors and Collaborators

    • Nicox Ophthalmics, Inc.

    Investigators

    • Study Director: Jose L Boyer, PhD, Nicox Ophthalmics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicox Ophthalmics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04630808
    Other Study ID Numbers:
    • NCX-470-03
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension
    Latanoprost

    Study Results

    No Results Posted as of Apr 27, 2022