Phase 2
N=224
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT04675242 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 — 4; 2 study eyes — p=0.4434
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NCX 4251 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nicox Ophthalmics, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 |
4; 2 | 0.4434 |
| SECONDARY Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms |
-16.4; -12.5 | 0.2105 |
| SECONDARY Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) |
-0.18; -0.13 | 0.5936 |
| SECONDARY Treatment-emergent Adverse Events |
12; 17 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04675242). 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.