Trial Outcomes & Findings for Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD) (NCT NCT04314362)

NCT ID: NCT04314362

Last Updated: 2023-01-25

Results Overview

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 were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012) 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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: Month 3
• Results posted on: 2023-01-25

Participant Flow

Participant milestones

Measure	AZR-MD-001 Active AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient	AZR-MD-001 Vehicle AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient
Overall Study STARTED	21	11
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	9	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Baseline characteristics by cohort

Measure	AZR-MD-001 Active n=21 Participants AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient	AZR-MD-001 Vehicle n=11 Participants AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient	Total n=32 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 18.9 • n=5 Participants	51.2 years STANDARD_DEVIATION 16.7 • n=7 Participants	47.5 years STANDARD_DEVIATION 18.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Australia	21 participants n=5 Participants	11 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Modified Intent to Treat

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 were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012)

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 Active n=17 Participants AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient	AZR-MD-001 Vehicle n=10 Participants AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient
Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)	12.8 Units on the MGS Scale Standard Deviation 11.3	8.8 Units on the MGS Scale Standard Deviation 5.6

Adverse Events

AZR-MD-001 Active

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

AZR-MD-001 Vehicle

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AZR-MD-001 Active n=19 participants at risk AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient	AZR-MD-001 Vehicle n=10 participants at risk AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient
Eye disorders Eye Pain	47.4% 9/19 • Number of events 13 • 3 Months	10.0% 1/10 • Number of events 2 • 3 Months
Eye disorders Eye Irritation	15.8% 3/19 • Number of events 6 • 3 Months	10.0% 1/10 • Number of events 1 • 3 Months
Eye disorders Ocular Discomfort	10.5% 2/19 • Number of events 2 • 3 Months	0.00% 0/10 • 3 Months

Additional Information

Charles Bosworth

Azura Ophthalmics

Phone: 17145598435

Email: charles.bosworth@azuraophthalmics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place