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

Blepharitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926026
• Other study ID #: NCX-4251-01
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: October 21, 2019

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Fluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
• Placebo
NCX 4251 Ophthalmic Suspension, 0%

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas

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