NCT04675242

Brief Summary

This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 14, 2022

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

December 15, 2020

Results QC Date

September 21, 2022

Last Update Submit

June 15, 2023

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15

    Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit

    Day 15 Visit

Secondary Outcomes (3)

  • Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms

    Day 15 Visit

  • Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)

    Day 15 Visit

  • Treatment-emergent Adverse Events

    29 days

Study Arms (2)

NCX 4251

EXPERIMENTAL

NCX 4251 Ophthalmic Suspension

Drug: NCX 4251

Placebo

PLACEBO COMPARATOR

Vehicle of NCX 4251 Ophthalmic Suspension

Drug: Placebo

Interventions

NCX 4251DRUG

NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily

NCX 4251
PlaceboDRUG

Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Results Point of Contact

Title
Doug Hubatsch
Organization
Nicox Ophthalmics, Inc.
hubatsch@nicox.com
832-360-3022

Study Officials

  • Nicox Ophthalmics

    Nicox Ophthalmics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 19, 2020

Study Start

December 14, 2020

Primary Completion

June 16, 2021

Study Completion

June 30, 2021

Last Updated

June 18, 2023

Results First Posted

December 14, 2022

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)