Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

• Sponsor: Azura Ophthalmics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04391959
• Collaborator: Avania (Industry)
• Enrollment: 31
• Locations: 5
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site: 6.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Drug: AZR-MD-001 Active; Drug: AZR-MD-001 Vehicle	Phase 2

Detailed Description

AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
• Actual Study Start Date: Jul 17, 2020
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZR-MD-001 Vehicle AZR-MD-001 Vehicle will be dosed up to twice weekly.	Drug: AZR-MD-001 Vehicle; AZR-MD-001 is a vehicle ophthalmic ointment; Other Names: AZR-MD-001 Vehicle is an ophthalmic ointment
Experimental: AZR-MD-001 Active AZR-MD-001 Active will be dosed up to twice weekly.	Drug: AZR-MD-001 Active; AZR-MD-001 is an active ophthalmic ointment; Other Names: AZR-MD-001 is an ophthalmic ointment

Outcome Measures

Primary Outcome Measures

1. Meibum Gland Secretion Score (MGS) [Month 3]

   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.

Secondary Outcome Measures

1. Total OSDI [Day 14 to Month 3]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female

• 18 years of age or older

• Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye

• Evidence of meibomian gland obstruction

• Reported dry eye signs and symptoms within the past 3 months

Exclusion Criteria:

• Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease

• Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study

• Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity

• BCVA worse than 20/40 in either eye

• Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fiona Stapleton	Sydney	New South Wales	Australia
2	Scott A Read	Brisbane	Queensland	Australia
3	Susan Thackwray	Maroochydore	Queensland	Australia
4	Jagrut Lallu	Auckland		New Zealand
5	Jennifer P Craig	Auckland		New Zealand

Sponsors and Collaborators

• Azura Ophthalmics
• Avania

Investigators

• Principal Investigator: Jacqueline Tan-Showyin, School of Optometry and Vision Science, University of New South Wales

Study Documents (Full-Text)

• Study Protocol - Mar 12, 2020
• Statistical Analysis Plan - Jan 25, 2021

More Information

Publications

None provided.

• Responsible Party: Azura Ophthalmics
• ClinicalTrials.gov Identifier: NCT04391959
• Other Study ID Numbers: AZ202001
• First Posted: May 18, 2020
• Last Update Posted: May 16, 2022
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

Participant Flow

Arm/Group Title	AZR-MD-001 Vehicle	AZR-MD-001 Active
Arm/Group Description	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 will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
Period Title: Overall Study
STARTED	16	15
COMPLETED	15	10
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	AZR-MD-001 Vehicle	AZR-MD-001 Active	Total
Arm/Group Description	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 will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment	Total of all reporting groups
Overall Participants	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (13.21)	56 (20.74)	57.3 (16.98)
Sex: Female, Male (Count of Participants)
Female	7 43.8%	8 57.1%	15 50%
Male	9 56.3%	6 42.9%	15 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 6.3%	5 35.7%	6 20%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 75%	9 64.3%	21 70%
More than one race	3 18.8%	0 0%	3 10%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Australia	11 68.8%	9 64.3%	20 66.7%
New Zealand	5 31.3%	5 35.7%	10 33.3%

Outcome Measures

1. Primary Outcome

Title	Meibum Gland Secretion Score (MGS)
Description	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.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

Target Population

Arm/Group Title	AZR-MD-001 Vehicle	AZR-MD-001 Active
Arm/Group Description	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 will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
Measure Participants	3	4
Mean (Standard Deviation) [score on a scale]	0.5 (1.83)	7.4 (1.53)

2. Secondary Outcome

Title	Total OSDI
Description	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.
Time Frame	Day 14 to Month 3

Outcome Measure Data

Analysis Population Description

Target Population

Arm/Group Title	AZR-MD-001 Vehicle	AZR-MD-001 Active
Arm/Group Description	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 will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
Measure Participants	3	4
Mean (Standard Deviation) [score on a scale]	-2.0 (3.49)	-8.1 (2.86)

Adverse Events

Time Frame	3 months
Arm/Group Title	AZR-MD-001 Vehicle		AZR-MD-001 Active
Arm/Group Description	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 will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment
All Cause Mortality
	AZR-MD-001 Vehicle		AZR-MD-001 Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/15 (6.7%)
Serious Adverse Events
	AZR-MD-001 Vehicle		AZR-MD-001 Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/15 (6.7%)
Renal and urinary disorders
dysuria	0/16 (0%)	0	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	AZR-MD-001 Vehicle		AZR-MD-001 Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		8/15 (53.3%)
Eye disorders
Eye irritation	1/16 (6.3%)	1	2/15 (13.3%)	2
Conjunctival hyperaemia	0/16 (0%)	0	1/15 (6.7%)	1
Dry eye	1/16 (6.3%)	1	1/15 (6.7%)	1
Eye pain	1/16 (6.3%)	1	4/15 (26.7%)	4
Eye pruritus	0/16 (0%)	0	2/15 (13.3%)	2
Foreign body sensation	0/16 (0%)	0	1/15 (6.7%)	1
Ocular discomfort	0/16 (0%)	0	2/15 (13.3%)	2
Photophobia	0/16 (0%)	0	1/15 (6.7%)	1
Vision blurred	0/16 (0%)	0	2/15 (13.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.