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

NCT03926026 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NCX-4251-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• COHORT 2: 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 to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis

  14 days

Study Arms (4)

NCX 4251 QD

EXPERIMENTAL

NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days

Drug: Fluticasone Propionate

Placebo QD

PLACEBO COMPARATOR

Placebo once daily for 14 days

Drug: Placebo

NCX 4251 BID

EXPERIMENTAL

NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days

Drug: Fluticasone Propionate

Placebo BID

PLACEBO COMPARATOR

Placebo twice daily for 14 days

Drug: Placebo

Interventions

Fluticasone Propionate DRUG

NCX 4251 Ophthalmic Suspension, 0.1%

Also known as: NCX 4251

NCX 4251 BID; NCX 4251 QD

Placebo DRUG

NCX 4251 Ophthalmic Suspension, 0%

Placebo BID; Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicox Ophthalmics, Inc.: lead

Study Sites (1)

Texan Eye

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Doug Hubatsch
• Organization: Nicox Ophthalmics, inc.

hubatsch@nicox.com

832-360-3022

Study Officials

• Nicox Ophthalmics

  Nicox Ophthalmics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: March 18, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: June 18, 2023
• Results First Posted: January 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)