Blepharitis
Conditions
Brief summary
This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.
Interventions
DRUGNCX 4251
NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
DRUGPlacebo
Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
Sponsors
Nicox Ophthalmics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* documented 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 |
|---|---|---|
| Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | Day 15 Visit | Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | Day 15 Visit | Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit |
| Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) | Day 15 Visit | Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit |
| Treatment-emergent Adverse Events | 29 days | Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated) |
Countries
United States
Participant flow
Recruitment details
eyecare practictioners' practices
Pre-assignment details
7 to 14 day screening period
Participants by arm
| Arm | Count |
|---|---|
| NCX 4251 NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily | 111 |
| Placebo Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily | 113 |
| Total | 224 |
Baseline characteristics
| Characteristic | NCX 4251 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 63 Participants | 111 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 50 Participants | 113 Participants |
| Age, Continuous | 61.4 years STANDARD_DEVIATION 13.75 | 63.2 years STANDARD_DEVIATION 14.31 | 62.3 years STANDARD_DEVIATION 14.03 |
| Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye | 4.6 units on a scale for study eyes | 4.7 units on a scale for study eyes | 4.7 units on a scale for study eyes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 105 Participants | 211 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Eye Dryness | 59.1 units on a scale for study eyes | 57.5 units on a scale for study eyes | 58.3 units on a scale for study eyes |
| Inferior Cornea Staining Score | 1.70 units on a scale for study eyes | 1.69 units on a scale for study eyes | 1.70 units on a scale for study eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 21 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 87 Participants | 171 Participants |
| Region of Enrollment United States | 111 participants | 113 participants | 224 participants |
| Sex: Female, Male Female | 75 Participants | 67 Participants | 142 Participants |
| Sex: Female, Male Male | 36 Participants | 46 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 113 |
| other Total, other adverse events | 12 / 111 | 20 / 113 |
| serious Total, serious adverse events | 0 / 111 | 0 / 113 |
Outcome results
Primary
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
Percentage of study eyes with Complete Cure (Score 0) in each of the following: Eyelid Margin Redness (0-none, 1-mild, 2-moderate, 3-severe), Eyelid Debris (0-none, 1-mild, 2-moderate, 3-severe), and Eyelid Discomfort (0-none, 1-mild, 2-moderate, 3-severe) at the Day 15 Visit
Time frame: Day 15 Visit
Population: Intent to treat (for study eyes with data for all 3 scales at the Baseline and Day 15 Visit)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| NCX 4251 | Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | 4 study eyes |
| Placebo | Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15 | 2 study eyes |
Comparison: Difference in the proportion of study eyes with complete curep-value: 0.443495% CI: [-11.5, 15.3]Fisher Exact
Secondary
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
Mean change from baseline in study eye fluorescein staining score (score of 0=none, 1=trace, 2=mild, 3=moderate, 4=severe) of the inferior cornea at the Day 15 Visit
Time frame: Day 15 Visit
Population: intent to treat (for study eyes with data at Baseline and Day 15)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NCX 4251 | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) | -0.18 units on a scale |
| Placebo | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea) | -0.13 units on a scale |
Comparison: Difference in the mean change from baselinep-value: 0.593695% CI: [-0.2, 0.1]ANCOVA
Secondary
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
Mean change from baseline in the eye dryness symptoms using a visual analogue scale (0 = no discomfort to 100 = maximal discomfort) at the Day 15 Visit
Time frame: Day 15 Visit
Population: intent to treat (in study eyes with data at Baseline and Day 15 Visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NCX 4251 | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | -16.4 units on a scale |
| Placebo | Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms | -12.5 units on a scale |
Comparison: Difference in the change from baseline between treatment groupsp-value: 0.210595% CI: [-9.5, 2.1]ANCOVA
Secondary
Treatment-emergent Adverse Events
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
Time frame: 29 days
Population: Safety population (all randomized subjects who received at least one dose of the intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NCX 4251 | Treatment-emergent Adverse Events | 12 Participants |
| Placebo | Treatment-emergent Adverse Events | 17 Participants |