Blepharitis
Conditions
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.
Interventions
DRUGFluticasone Propionate
NCX 4251 Ophthalmic Suspension, 0.1%
DRUGPlacebo
NCX 4251 Ophthalmic Suspension, 0%
Sponsors
Nicox Ophthalmics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-masked
Intervention model description
sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NCX 4251 QD (Cohort 1) NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% | 10 |
| NCX 4251 QD (Cohort 1) NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% | 10 |
| Placebo QD (Cohort 1) Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0% | 5 |
| Placebo QD (Cohort 1) Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0% | 5 |
| NCX 4251 QD (Cohort 2) NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% | 10 |
| NCX 4251 QD (Cohort 2) NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1% | 10 |
| Placebo QD (Cohort 2) Placebo twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0% | 11 |
| Placebo QD (Cohort 2) Placebo twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0% | 11 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | NCX 4251 QD (Cohort 1) | Placebo QD (Cohort 1) | NCX 4251 QD (Cohort 2) | Placebo QD (Cohort 2) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 6 Participants | 4 Participants | 5 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 4 Participants | 1 Participants | 5 Participants | 5 Participants |
| Age, Continuous | 65.4 years | 63.5 years | 67.8 years | 58.3 years | 64.5 years |
| Composite score of eyelid discomfort, eyelid margin redness, and debris | 4.8 units on a scale | 4.7 units on a scale | 5 units on a scale | 4.6 units on a scale | 4.5 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 9 Participants | 5 Participants | 9 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 10 Participants | 5 Participants | 9 Participants | 11 Participants |
| Region of Enrollment United States | 36 participants | 10 participants | 5 participants | 10 participants | 11 participants |
| Sex: Female, Male Female | 21 Participants | 7 Participants | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 15 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 1 / 10 | 0 / 5 | 5 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 | 0 / 10 | 0 / 11 |
Outcome results
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)
Time frame: 14 days
Population: intent-to-treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NCX 4251 (Cohort 1 & 2 Combined) | COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -2.0 units on a scale |
| Placebo (Cohort 1 & 2 Combined) | COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -1.2 units on a scale |
p-value: 0.047195% CI: [-1.5, 0]t-test, 2 sided
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)
Time frame: 14 days
Population: intent-to-treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NCX 4251 (Cohort 1 & 2 Combined) | COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -2.2 units on a scale |
| Placebo (Cohort 1 & 2 Combined) | COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -1.2 units on a scale |
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)
Time frame: 14 days
Population: intent-to-treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NCX 4251 (Cohort 1 & 2 Combined) | COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -1.7 units on a scale |
| Placebo (Cohort 1 & 2 Combined) | COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis | -1.1 units on a scale |