Overview

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

Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nicox Ophthalmics, Inc.
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