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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: NCX 4251
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCX 4251<br>NCX 4251 Ophthalmic Suspension | Drug: NCX 4251<br>* NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily<br>|
| Placebo Comparator: Placebo<br>Vehicle of NCX 4251 Ophthalmic Suspension | Drug: Placebo<br>* Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 29 days |