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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-masked

Study Groups

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NCX 4251

NCX 4251 Ophthalmic Suspension

Group Type EXPERIMENTAL

NCX 4251

Intervention Type DRUG

NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily

Placebo

Vehicle of NCX 4251 Ophthalmic Suspension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Interventions

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NCX 4251

NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily

Intervention Type DRUG

Placebo

Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No