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

NicOx

Status and phase: Completed; Phase 2

Conditions: Blepharitis

Treatments: Drug: NCX 4251; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04675242

NCX-4251-02

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

NCX 4251

Experimental group

Description:

NCX 4251 Ophthalmic Suspension

Treatment:

Drug: NCX 4251

Placebo

Placebo Comparator group

Description:

Vehicle of NCX 4251 Ophthalmic Suspension

Treatment:

Drug: Placebo