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

Phase 2

Completed

• Conditions: Blepharitis
• Interventions: Drug: Placebo; Drug: Fluticasone Propionate

• Registration Number: NCT03926026
• Lead Sponsor: Nicox Ophthalmics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Disposition First Submitted: 2020-11-04
• Results First Submitted: 2022-09-21
• Results First Submitted QC: 2022-12-23
• Disposition First Submitted QC: 2022-12-23
• Results First Posted: 2023-01-19
• Disposition First Posted: 2023-01-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo QD	Placebo	Placebo once daily for 14 days
Placebo BID	Placebo	Placebo twice daily for 14 days
NCX 4251 QD	Fluticasone Propionate	NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
NCX 4251 BID	Fluticasone Propionate	NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Texan Eye; 🇺🇸 Austin, Texas, United States