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

Phase 2

Completed

• Conditions: Blepharitis
• Interventions: Drug: NCX 4251; Drug: Placebo

• Registration Number: NCT04675242
• Lead Sponsor: Nicox Ophthalmics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Primary Completion: 2021-06-16
• Study Completion: 2021-06-30
• Results First Submitted: 2022-09-21
• Results First Submitted QC: 2022-11-17
• Results First Posted: 2022-12-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCX 4251	NCX 4251	NCX 4251 Ophthalmic Suspension
Placebo	Placebo	Vehicle of NCX 4251 Ophthalmic Suspension

Primary Outcome Measures

Name	Time	Method
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	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 Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events	29 days	Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	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
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	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

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States