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

NicOx

Status and phase: Completed; Phase 2

Conditions: Blepharitis

Treatments: Drug: Fluticasone Propionate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926026

NCX-4251-01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

NCX 4251 QD

Experimental group

Description:

NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days

Treatment:

Drug: Fluticasone Propionate

Placebo QD

Placebo Comparator group

Description:

Placebo once daily for 14 days

Treatment:

Drug: Placebo

NCX 4251 BID

Experimental group

Description:

NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days

Treatment:

Drug: Fluticasone Propionate

Placebo BID

Placebo Comparator group

Description:

Placebo twice daily for 14 days

Treatment:

Drug: Placebo