search
Back to results

Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (Mississippi)

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NCX 4251
Placebo
Sponsored by
Nicox Ophthalmics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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

Sites / Locations

  • Eye Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NCX 4251

Placebo

Arm Description

NCX 4251 Ophthalmic Suspension

Vehicle of NCX 4251 Ophthalmic Suspension

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit
Treatment-emergent Adverse Events
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)

Full Information

First Posted
December 15, 2020
Last Updated
June 15, 2023
Sponsor
Nicox Ophthalmics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04675242
Brief Title
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Acronym
Mississippi
Official Title
Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nicox Ophthalmics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-masked
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NCX 4251
Arm Type
Experimental
Arm Description
NCX 4251 Ophthalmic Suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle of NCX 4251 Ophthalmic Suspension
Intervention Type
Drug
Intervention Name(s)
NCX 4251
Intervention Description
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
Primary Outcome Measure Information:
Title
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
Description
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
Time Frame
Day 15 Visit
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
Description
Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit
Time Frame
Day 15 Visit
Title
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
Description
Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit
Time Frame
Day 15 Visit
Title
Treatment-emergent Adverse Events
Description
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
Time Frame
29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicox Ophthalmics
Organizational Affiliation
Nicox Ophthalmics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis

We'll reach out to this number within 24 hrs