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

• Status: Completed
• Trial end date: 2019-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicox Ophthalmics, Inc.
• Treatments: Fluticasone; Xhance

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