Trial Outcomes & Findings for Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction (NCT NCT04469998)
NCT ID: NCT04469998
Last Updated: 2023-07-21
Results Overview
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
22 Days
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
AXR-270 Low Dose
AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream 0.2%
|
AXR-270 High Dose
AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream 2%
|
AXR-270 Vehicle
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
|---|---|---|---|
|
Full Analysis Set (ITT Population)
STARTED
|
43
|
44
|
42
|
|
Full Analysis Set (ITT Population)
COMPLETED
|
42
|
43
|
42
|
|
Full Analysis Set (ITT Population)
NOT COMPLETED
|
1
|
1
|
0
|
|
Safety Set (as Treated)
STARTED
|
42
|
43
|
43
|
|
Safety Set (as Treated)
COMPLETED
|
41
|
42
|
43
|
|
Safety Set (as Treated)
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
AXR-270 Low Dose
n=43 Participants
AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 High Dose
n=44 Participants
AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 Vehicle
n=42 Participants
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
42 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Total Meibomian Gland Dysfunction Score
|
9.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
9.7 units on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 22 DaysPopulation: Safety Set
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Outcome measures
| Measure |
AXR-270 Low Dose
n=42 Participants
AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 High Dose
n=43 Participants
AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 Vehicle
n=43 Participants
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
|---|---|---|---|
|
Adverse Events
Non-ocular TEAEs
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
|
Adverse Events
Non-ocular Serious TEAEs
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Adverse Events
Ocular TEAEs
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
|
Adverse Events
Ocular Serious TEAEs
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 22 DaysPopulation: Full Analysis Set (Intent-to-Treat)
Change from Baseline in total MGD score (Study Eyelid): The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome. Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.
Outcome measures
| Measure |
AXR-270 Low Dose
n=42 Participants
AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 High Dose
n=42 Participants
AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 Vehicle
n=41 Participants
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
|---|---|---|---|
|
Total Meibomian Gland Dysfunction Score
|
-0.9 score on a scale
Standard Deviation 2.3
|
-1.7 score on a scale
Standard Deviation 2.1
|
-2.1 score on a scale
Standard Deviation 2.6
|
Adverse Events
AXR-270 Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AXR-270 High Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AXR-270 Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AXR-270 Low Dose
n=42 participants at risk
AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 High Dose
n=43 participants at risk
AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream
|
AXR-270 Vehicle
n=43 participants at risk
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
|---|---|---|---|
|
Infections and infestations
Covid
|
0.00%
0/42 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
2.3%
1/43 • Number of events 1 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
|
Blood and lymphatic system disorders
increased blood creatine phosphokinase
|
0.00%
0/42 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
2.3%
1/43 • Number of events 1 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
|
Renal and urinary disorders
mild urinary tract infection
|
2.4%
1/42 • Number of events 1 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
|
Nervous system disorders
mild headache
|
0.00%
0/42 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
2.3%
1/43 • Number of events 1 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
|
Eye disorders
mild eyelid pruritus
|
0.00%
0/42 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
2.3%
1/43 • Number of events 1 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
|
Eye disorders
mild eyelid erythema, edema
|
0.00%
0/42 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
0.00%
0/43 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
2.3%
1/43 • Number of events 3 • 22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement defined what qualifies as Confidential Information and restrictions on publication of study results.
- Publication restrictions are in place
Restriction type: OTHER