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

Sponsor
Nicox Ophthalmics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03657797
Collaborator
(none)
656
Enrollment
1
Location
4
Arms
12.7
Actual Duration (Months)
51.6
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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NCX 470
  • Drug: Latanoprost 0.005%
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
656 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Aug 23, 2019
Actual Study Completion Date :
Aug 23, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NCX 470 0.021%

NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks

Drug: NCX 470
NCX 470 Ophthalmic Solution
Experimental: NCX 470 0.042%

NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks

Drug: NCX 470
NCX 470 Ophthalmic Solution
Experimental: NCX 470 0.065%

NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks

Drug: NCX 470
NCX 470 Ophthalmic Solution
Active Comparator: Latanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Drug: Latanoprost 0.005%
Latanoprost 0.005% Ophthalmic Solution
Other Names:
  • Latanoprost

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction from baseline in mean diurnal IOP at the Week 4 Visit in the study eye [4 weeks]

    Secondary Outcome Measures

    1. Number of subjects with adverse events as a measure of safety and tolerability [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 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 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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Texan Eye Austin Texas United States 78731

    Sponsors and Collaborators

    • Nicox Ophthalmics, Inc.

    Investigators

    • Study Director: Tomas Navratil, PhD, Nicox Ophthalmics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicox Ophthalmics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03657797
    Other Study ID Numbers:
    • NCX-470-17001
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Sep 24, 2020
    Last Verified:
    Sep 1, 2020
    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 Sep 24, 2020