Phase 2 N=36 Randomized Double-blind Treatment

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

Blepharitis

Bottom Line

View on ClinicalTrials.gov: NCT03926026 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis — -2.0; -1.2 units on a scale — p=0.0471

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fluticasone Propionate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nicox Ophthalmics, Inc.
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis	-2.0; -1.2	0.0471 sig
SECONDARY COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis	-1.7; -1.1	—
SECONDARY COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis	-2.2; -1.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03926026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.