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

Blepharitis Clinical Trial

— Mississippi  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675242
• Other study ID #: NCX-4251-02
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2023
• Source: Nicox Ophthalmics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 30, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• NCX 4251
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
• Placebo
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Nicox Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15	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	Day 15 Visit
Secondary	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms	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	Day 15 Visit
Secondary	Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)	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	Day 15 Visit
Secondary	Treatment-emergent Adverse Events	Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)	29 days