Trial Outcomes & Findings for Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis (NCT NCT03926026)
NCT ID: NCT03926026
Last Updated: 2023-06-18
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
14 days
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
NCX 4251 QD -- Cohort 1
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo QD -- Cohort 1
Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
NCX 4251 BID -- Cohort 2
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo BID -- Cohort 2
Placebo twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
5
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
Baseline characteristics by cohort
| Measure |
NCX 4251 QD (Cohort 1)
n=10 study eyes
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo QD (Cohort 1)
n=5 study eyes
Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
NCX 4251 QD (Cohort 2)
n=10 study eyes
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo QD (Cohort 2)
n=11 study eyes
Placebo twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
Total
n=36 study eyes
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
67.8 years
n=7 Participants
|
58.3 years
n=5 Participants
|
64.5 years
n=4 Participants
|
65.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Composite score of eyelid discomfort, eyelid margin redness, and debris
|
4.7 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
4.6 units on a scale
n=5 Participants
|
4.5 units on a scale
n=4 Participants
|
4.8 units on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: intent-to-treat population
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)
Outcome measures
| Measure |
NCX 4251 (Cohort 1 & 2 Combined)
n=20 study eyes
NCX 4251 Ophthalmic Suspension, 0.1% once or twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo (Cohort 1 & 2 Combined)
n=16 study eyes
Placebo once or twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|---|---|---|
|
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
Interval -4.0 to 1.0
|
-1.2 units on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: intent-to-treat population
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)
Outcome measures
| Measure |
NCX 4251 (Cohort 1 & 2 Combined)
n=10 study eyes
NCX 4251 Ophthalmic Suspension, 0.1% once or twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo (Cohort 1 & 2 Combined)
n=11 study eyes
Placebo once or twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|---|---|---|
|
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
Interval -3.0 to -1.0
|
-1.1 units on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: intent-to-treat population
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)
Outcome measures
| Measure |
NCX 4251 (Cohort 1 & 2 Combined)
n=10 study eyes
NCX 4251 Ophthalmic Suspension, 0.1% once or twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo (Cohort 1 & 2 Combined)
n=5 study eyes
Placebo once or twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|---|---|---|
|
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
Interval -4.0 to 1.0
|
-1.2 units on a scale
Interval -2.0 to 0.0
|
Adverse Events
NCX 4251 QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NCX 4251 BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NCX 4251 QD
n=10 participants at risk
NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo QD
n=5 participants at risk
Placebo once daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
NCX 4251 BID
n=10 participants at risk
NCX 4251 Ophthalmic Suspension, 0.1% twice daily for 14 days
Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
|
Placebo BID
n=11 participants at risk
Placebo twice daily for 14 days
Placebo: NCX 4251 Ophthalmic Suspension, 0%
|
|---|---|---|---|---|
|
Eye disorders
eyelid margin crusting
|
10.0%
1/10 • Number of events 1 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/10 • 28 days
|
0.00%
0/11 • 28 days
|
|
Eye disorders
periorbital oedema
|
10.0%
1/10 • Number of events 1 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/10 • 28 days
|
0.00%
0/11 • 28 days
|
|
Skin and subcutaneous tissue disorders
pruritus
|
10.0%
1/10 • Number of events 1 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/10 • 28 days
|
0.00%
0/11 • 28 days
|
|
Eye disorders
conjunctival hemorrhage
|
0.00%
0/10 • 28 days
|
0.00%
0/5 • 28 days
|
30.0%
3/10 • Number of events 3 • 28 days
|
0.00%
0/11 • 28 days
|
|
General disorders
instillation site pruritus
|
0.00%
0/10 • 28 days
|
0.00%
0/5 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
0.00%
0/11 • 28 days
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/10 • 28 days
|
0.00%
0/5 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
0.00%
0/11 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place