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Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis

Sponsor
Nicox Ophthalmics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03926026
Collaborator
(none)
44
Enrollment
1
Location
4
Arms
7.1
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of blepharitis. The study will be performed in two sequential dose escalating cohorts.

The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluticasone Propionate
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Masking:
Double (Participant, Investigator)
Masking Description:
double-masked
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation, Phase 2 Study Evaluating the Safety and Tolerability of NCX 4251 (Fluticasone Propionate Nanocrystal) Ophthalmic Suspension, 0.1% QD and BID for the Treatment of Acute Exacerbations of Blepharitis
Actual Study Start Date :
Mar 18, 2019
Actual Primary Completion Date :
Oct 21, 2019
Actual Study Completion Date :
Oct 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NCX 4251 QD

NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days

Drug: Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
Other Names:
  • NCX 4251

    		•
    Placebo Comparator: Placebo QD

    Placebo once daily for 14 days

    Drug: Placebo
    NCX 4251 Ophthalmic Suspension, 0%
    Experimental: NCX 4251 BID

    NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days

    Drug: Fluticasone Propionate
    NCX 4251 Ophthalmic Suspension, 0.1%
    Other Names:
  • NCX 4251

    		•
    Placebo Comparator: Placebo BID

    Placebo twice daily for 14 days

    Drug: Placebo
    NCX 4251 Ophthalmic Suspension, 0%

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent ocular and systemic adverse events (safety and tolerability) [28 days]

      Incidence of treatment-emergent ocular and systemic adverse events (safety and tolerability)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits

    • have a qualifying best-corrected visual acuity

    Exclusion Criteria:

    • abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery

    • IOP > 21 mmHg at Screening or Baseline/Day 1 Visits

    • use of steroids in the past 30 days or retinoids in the past 12 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:
    NCT03926026
    Other Study ID Numbers:
    • NCX-4251-01
    First Posted:
    Apr 24, 2019
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 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:
    Blepharitis
    Fluticasone
    Xhance

    Study Results

    No Results Posted as of Nov 13, 2020