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Completed

NCT Number: NCT04675242

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

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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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

Eye Research Foundation

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

NCX 4251

Drug

NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily

Placebo

Drug

Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Primary outcomes

  1. Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15

    Time frame: Day 15 Visit

    Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit

Secondary outcomes

  1. Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms

    Time frame: Day 15 Visit

    Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit

  2. Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)

    Time frame: Day 15 Visit

    Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit

  3. Treatment-emergent Adverse Events

    Time frame: 29 days

    Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study title

Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)

Acronym: Mississippi

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
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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