Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
Primary Purpose
Blepharitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluticasone Propionate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
Eligibility Criteria
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
Sites / Locations
- Texan Eye
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
NCX 4251 QD
Placebo QD
NCX 4251 BID
Placebo BID
Arm Description
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Placebo once daily for 14 days
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Placebo twice daily for 14 days
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03926026
Brief Title
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nicox Ophthalmics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Masking
ParticipantInvestigator
Masking Description
double-masked
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NCX 4251 QD
Arm Type
Experimental
Arm Description
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 14 days
Arm Title
NCX 4251 BID
Arm Type
Experimental
Arm Description
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Other Intervention Name(s)
NCX 4251
Intervention Description
NCX 4251 Ophthalmic Suspension, 0.1%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NCX 4251 Ophthalmic Suspension, 0%
Primary Outcome Measure Information:
Title
COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
Description
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)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
Description
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)
Time Frame
14 days
Title
COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
Description
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)
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicox Ophthalmics
Organizational Affiliation
Nicox Ophthalmics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
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