Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis (NCT NCT04675242)
NCT ID: NCT04675242
Last Updated: 2023-06-18
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
Day 15 Visit
Results posted on
2023-06-18
Participant Flow
eyecare practictioners' practices
7 to 14 day screening period
Unit of analysis: study eye
Participant milestones
| Measure |
NCX 4251
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
Overall Study
STARTED
|
111 111
|
113 113
|
|
Overall Study
COMPLETED
|
109 109
|
112 112
|
|
Overall Study
NOT COMPLETED
|
2 2
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Baseline characteristics by cohort
| Measure |
NCX 4251
n=111 Participants
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=113 Participants
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 13.75 • n=99 Participants
|
63.2 years
STANDARD_DEVIATION 14.31 • n=107 Participants
|
62.3 years
STANDARD_DEVIATION 14.03 • n=206 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=99 Participants
|
113 participants
n=107 Participants
|
224 participants
n=206 Participants
|
|
Composite Score of Eyelid Margin Redness + Eyelid Debris + Eyelid Discomfort in the study eye
|
4.6 units on a scale for study eyes
n=99 Participants
|
4.7 units on a scale for study eyes
n=107 Participants
|
4.7 units on a scale for study eyes
n=206 Participants
|
|
Eye Dryness
|
59.1 units on a scale for study eyes
n=99 Participants
|
57.5 units on a scale for study eyes
n=107 Participants
|
58.3 units on a scale for study eyes
n=206 Participants
|
|
Inferior Cornea Staining Score
|
1.70 units on a scale for study eyes
n=99 Participants
|
1.69 units on a scale for study eyes
n=107 Participants
|
1.70 units on a scale for study eyes
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 15 VisitPopulation: Intent to treat (for study eyes with data for all 3 scales at the Baseline and 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
Outcome measures
| Measure |
NCX 4251
n=109 study eyes
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=111 study eyes
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
|
4 study eyes
|
2 study eyes
|
SECONDARY outcome
Timeframe: Day 15 VisitPopulation: intent to treat (in study eyes with data at Baseline and 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
Outcome measures
| Measure |
NCX 4251
n=109 study eyes
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=112 study eyes
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
|
-16.4 units on a scale
Interval -20.7 to -12.0
|
-12.5 units on a scale
Interval -16.5 to -8.5
|
SECONDARY outcome
Timeframe: Day 15 VisitPopulation: intent to treat (for study eyes with data at Baseline and Day 15)
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
Outcome measures
| Measure |
NCX 4251
n=109 study eyes
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=112 study eyes
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
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
Interval -0.34 to -0.02
|
-0.13 units on a scale
Interval -0.26 to 0.01
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Safety population (all randomized subjects who received at least one dose of the intervention)
Number of participants with treatment-emergent adverse events (an adverse event that occurred on or after treatment with the intervention was initiated)
Outcome measures
| Measure |
NCX 4251
n=111 Participants
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=113 Participants
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
Treatment-emergent Adverse Events
|
12 Participants
|
17 Participants
|
Adverse Events
NCX 4251
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NCX 4251
n=111 participants at risk
NCX 4251 Ophthalmic Suspension
NCX 4251: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
|
Placebo
n=113 participants at risk
Vehicle of NCX 4251 Ophthalmic Suspension
Placebo: Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.90%
1/111 • Number of events 1 • 29 days
|
1.8%
2/113 • Number of events 2 • 29 days
|
|
Eye disorders
Eye pruritus
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Eye disorders
Vitreous detachment
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Eye disorders
Eyelids pruritus
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
General disorders
Instillation site pain
|
0.90%
1/111 • Number of events 1 • 29 days
|
4.4%
5/113 • Number of events 5 • 29 days
|
|
General disorders
Instillation site oedema
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Eye disorders
Conjunctival hyperaemia
|
0.90%
1/111 • Number of events 2 • 29 days
|
0.00%
0/113 • 29 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Injury, poisoning and procedural complications
Splinter
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
|
Nervous system disorders
Ageusia
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Nervous system disorders
Headache
|
0.90%
1/111 • Number of events 1 • 29 days
|
0.00%
0/113 • 29 days
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/111 • 29 days
|
0.88%
1/113 • Number of events 1 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place