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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2019-10-21

Brief Summary

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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.

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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

sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-masked

Study Groups

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NCX 4251 QD

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

Group Type EXPERIMENTAL

Fluticasone Propionate

Intervention Type DRUG

NCX 4251 Ophthalmic Suspension, 0.1%

Placebo QD

Placebo once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NCX 4251 Ophthalmic Suspension, 0%

NCX 4251 BID

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

Group Type EXPERIMENTAL

Fluticasone Propionate

Intervention Type DRUG

NCX 4251 Ophthalmic Suspension, 0.1%

Placebo BID

Placebo twice daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NCX 4251 Ophthalmic Suspension, 0%

Interventions

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Fluticasone Propionate

NCX 4251 Ophthalmic Suspension, 0.1%

Intervention Type DRUG

Placebo

NCX 4251 Ophthalmic Suspension, 0%

Intervention Type DRUG

Other Intervention Names

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NCX 4251

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No