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Completed

NCT Number: NCT03926026

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

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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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Texan Eye

Austin, Texas, 78731, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

NCX 4251 Ophthalmic Suspension, 0.1%

Other names: NCX 4251

Placebo

Drug

NCX 4251 Ophthalmic Suspension, 0%

Primary outcomes

  1. COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis

    Time frame: 14 days

    COHORT 1 and 2 COMBINED: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale)

Secondary outcomes

  1. COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis

    Time frame: 14 days

    COHORT 2: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale)

  2. COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis

    Time frame: 14 days

    COHORT 1: Mean change from baseline in Composite (Sum) Score of Eyelid Margin Redness (0=none to 3=severe scale), Eyelid Debris (0=none to 3=severe scale), and Eyelid Discomfort (0=none to 3=severe scale)

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2019
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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