Trial Outcomes & Findings for Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) (NCT NCT04391959)
NCT ID: NCT04391959
Last Updated: 2022-05-16
Results Overview
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.
COMPLETED
PHASE2
31 participants
Month 3
2022-05-16
Participant Flow
Participant milestones
| Measure |
AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Baseline characteristics by cohort
| Measure |
AZR-MD-001 Vehicle
n=16 Participants
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
n=14 Participants
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 13.21 • n=99 Participants
|
56 years
STANDARD_DEVIATION 20.74 • n=107 Participants
|
57.3 years
STANDARD_DEVIATION 16.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 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
|
5 Participants
n=107 Participants
|
6 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 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
Australia
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Target Population
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.
Outcome measures
| Measure |
AZR-MD-001 Vehicle
n=3 Participants
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
n=4 Participants
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
|---|---|---|
|
Meibum Gland Secretion Score (MGS)
|
0.5 score on a scale
Standard Deviation 1.83
|
7.4 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Day 14 to Month 3Population: Target Population
Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answereda\] X 100)/(\[total number of questions answered\] X 4). Questions answered with N/A were excluded in the calculation of total OSDI.
Outcome measures
| Measure |
AZR-MD-001 Vehicle
n=3 Participants
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
n=4 Participants
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
|---|---|---|
|
Total OSDI
|
-2.0 score on a scale
Standard Deviation 3.49
|
-8.1 score on a scale
Standard Deviation 2.86
|
Adverse Events
AZR-MD-001 Vehicle
AZR-MD-001 Active
Serious adverse events
| Measure |
AZR-MD-001 Vehicle
n=16 participants at risk
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
n=15 participants at risk
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
|---|---|---|
|
Renal and urinary disorders
dysuria
|
0.00%
0/16 • 3 months
|
6.7%
1/15 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
AZR-MD-001 Vehicle
n=16 participants at risk
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
AZR-MD-001 Active
n=15 participants at risk
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
|
|---|---|---|
|
Eye disorders
Eye irritation
|
6.2%
1/16 • Number of events 1 • 3 months
|
13.3%
2/15 • Number of events 2 • 3 months
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/16 • 3 months
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 1 • 3 months
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Number of events 1 • 3 months
|
26.7%
4/15 • Number of events 4 • 3 months
|
|
Eye disorders
Eye pruritus
|
0.00%
0/16 • 3 months
|
13.3%
2/15 • Number of events 2 • 3 months
|
|
Eye disorders
Foreign body sensation
|
0.00%
0/16 • 3 months
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/16 • 3 months
|
13.3%
2/15 • Number of events 2 • 3 months
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • 3 months
|
6.7%
1/15 • Number of events 1 • 3 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • 3 months
|
13.3%
2/15 • Number of events 2 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60