NCT03926026

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Nicox Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	NCX 4251 Ophthalmic Suspension, 0.1%
DRUG	Placebo	NCX 4251 Ophthalmic Suspension, 0%

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-10-21
• Completion: 2019-10-21
• First posted: 2019-04-24
• Last updated: 2023-06-18
• Results posted: 2023-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study