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

Study Overview
=================
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.

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

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCX 4251 QD<br>NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days | Drug: Fluticasone Propionate<br>* NCX 4251 Ophthalmic Suspension, 0.1%<br>* Other names: NCX 4251;|
| Placebo Comparator: Placebo QD<br>Placebo once daily for 14 days | Drug: Placebo<br>* NCX 4251 Ophthalmic Suspension, 0%<br>|
| Experimental: NCX 4251 BID<br>NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days | Drug: Fluticasone Propionate<br>* NCX 4251 Ophthalmic Suspension, 0.1%<br>* Other names: NCX 4251;|
| Placebo Comparator: Placebo BID<br>Placebo twice daily for 14 days | Drug: Placebo<br>* NCX 4251 Ophthalmic Suspension, 0%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 1 and 2 COMBINED: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 2: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | 14 days | 
| COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | COHORT 1: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale) | 14 days |