Trial Outcomes & Findings for An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD) (NCT NCT03972501)

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 methods published by 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

Target enrollment

26 participants

Primary outcome timeframe

Month 4

Results posted on

2023-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	AZR-MD-001 Vehicle AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment	AZR-MD-001 Active Dose AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment
Overall Study STARTED	9	17
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	2	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZR-MD-001 Vehicle n=9 Participants AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment	AZR-MD-001 Active Dose n=17 Participants AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment	Total n=26 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 19.2 • n=5 Participants	21.4 years STANDARD_DEVIATION 32.8 • n=7 Participants	32.1 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	6 Participants n=5 Participants	11 Participants n=7 Participants	17 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Australia	9 participants n=5 Participants	17 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 4

Population: Modified Intent to Treat

Outcome measures

Outcome measures
Measure	AZR-MD-001 Vehicle n=7 Participants AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment	AZR-MD-001 Active Dose n=7 Participants AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).	12.1 Units on the Meibomian Gland Score scale Standard Deviation 10.7	16 Units on the Meibomian Gland Score scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: Month 4

Population: Modified Intent to Treat

The MGYLS can range from 0 (highly abnormal) to 15 (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. The number of glands secreting any liquid were counted using the methods published by 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

Outcome measures
Measure	AZR-MD-001 Vehicle n=7 Participants AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment	AZR-MD-001 Active Dose n=7 Participants AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).	3.9 Units on the MGYLS scale Standard Deviation 3.2	4.1 Units on the MGYLS scale Standard Deviation 4.4

Adverse Events

AZR-MD-001 Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AZR-MD-001 Active Dose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AZR-MD-001 Vehicle n=7 participants at risk AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment	AZR-MD-001 Active Dose n=13 participants at risk AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment
Eye disorders Eye Irritation	0.00% 0/7 • 4 Months	15.4% 2/13 • Number of events 2 • 4 Months
Eye disorders Eye Pain	0.00% 0/7 • 4 Months	7.7% 1/13 • Number of events 1 • 4 Months

Additional Information

Charles Bosworth

Azura Ophthalmics

Phone: 17145598435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place