Meibomian Gland DysfunctionPhase 2NCT03652051

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

A Phase 2 study testing AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose and AZR-MD-001 High Dose in people with Meibomian Gland Dysfunction and Dry Eye, run by Azura Ophthalmics at 30 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Meibomian Gland Dysfunction, Dry Eye
What is being tested?: AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose and AZR-MD-001 High Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 321 participants
Where: 30 sitesin 3 countries
Study dates: 10 Sep 2018to 19 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

Canada16 sites

Prism Eye Institute
Brampton, Ontario, 6Y 4M3
Seema Eye Care
Calgary, Alberta, AB T2V 4J2
FYI Doctors
Campbell River, British Columbia
Ocean Optometry
Halifax, Nova Scotia, NS B3J 1J7
Miller Optometry
Halifax, Nova Scotia
Cliantha Research
Mississauga, Ontario, L4W 1A4
Precision Cornea Centre
Ottawa, Ontario, K1G 3Y7
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
FYI Doctors
Toronto, Ontario, L3R 1N1
Healthpoint
Toronto, Ontario, L6T 0G1
Eyes on Sheppard Clinic
Toronto, Ontario, M2N3A1
Toronto Eye Care
Toronto, Ontario, M4W 0A7
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
VCH Research Institute.
Vancouver, British Columbia, V5Z 3N8
Ophthalmology
Vancouver, British Columbia, V6H1H2
School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

Australia12 sites

Eye Laser Specialists
Armadale, Victoria, 3143
Bendigo Eye Clinic
Bendigo, Victoria, 3550
Queensland University of Technology
Brisbane, Queensland, 4059
Vision Eye Institute
Chatswood, New South Wales, 2067
Waverley Eye Clinic
Glen Waverley, Victoria, 3150
Downie Laboratory, Department of Optometry and Vision Sciences
Melbourne, Victoria, 3053
Queensland Eye Institute
South Brisbane, Queensland, 4101
Eye Associates
Sydney, New South Wales, 2000
Sydney Eye Hospital
Sydney, New South Wales, 2000
School of Optometry and Vision Science, University of New South Wales
Sydney, New South Wales, 2052
Ophthalmic Trials Australia
Teneriffe, Queensland, 4005
Deakin University
Waurn Ponds, Victoria, 3216

Other trials in Australia

New Zealand2 sites

University of Auckland
Auckland, 1023
AucklandEye
Auckland, 1050

Other trials in New Zealand

About this study

Official title: A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Read the detailed description

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Conditions: Meibomian Gland Dysfunction, Dry Eye
Being tested: AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose, AZR-MD-001 High Dose, AZR-MD-001 Vehicle
Medical subject headings: Meibomian Gland Dysfunction, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZR-MD-001 Low DoseDrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Mid DoseDrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 High DoseDrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 VehicleDrug
AZR-MD-001 is a vehicle ophthalmic ointment

Study groups in NCT03652051
Study group	Role	What they receive
AZR-MD-001 Low Dose	Experimental	AZR-MD-001 Low Dose will be dosed up to once daily. Receives: Drug: AZR-MD-001 Low Dose
AZR-MD-001 Mid Dose	Experimental	AZR-MD-001 Mid Dose will be dosed up to once daily. Receives: Drug: AZR-MD-001 Mid Dose
AZR-MD-001 High Dose	Experimental	AZR-MD-001 High Dose will be dosed up to once daily. Receives: Drug: AZR-MD-001 High Dose
AZR-MD-001 Vehicle	Sham comparator	AZR-MD-001 Vehicle will be dosed up to once daily. Receives: Drug: AZR-MD-001 Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Meibomian Glands Yielding Liquid Secretion (MGYLS)
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Measured: Value at month 3 minus value at baseline
Ocular Surface Disease Index (OSDI) Total Score
Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)
Measured: Value at month 3 minus value at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201819 Oct 2022

First posted29 Aug 2018
Study start10 Sep 2018
Primary completion14 Sep 2022
Study completion19 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03652051
Sponsor's protocol ID: AZ201801
Status last verified: Feb 2024
First submitted: 27 Aug 2018
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.
PubMed 37478969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Not yet recruiting
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
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All Meibomian Gland Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)
ClinicalTrials.gov ID: NCT03652051
Acronym / sponsor ID: AZ201801
Conditions: Meibomian Gland Dysfunction, Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: Azura OphthalmicsIndustry (pharma, biotech, devices)
Collaborators: Syneos Health, Cliantha Research
Study start: 10 Sep 2018 (actual)
Primary completion: 14 Sep 2022 (actual)
Study completion: 19 Oct 2022 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 28 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AZR-MD-001 Low Dose	Experimental	Drug: AZR-MD-001 Low DoseAZR-MD-001 Low Dose will be dosed up to once daily.
AZR-MD-001 Mid Dose	Experimental	Drug: AZR-MD-001 Mid DoseAZR-MD-001 Mid Dose will be dosed up to once daily.
AZR-MD-001 High Dose	Experimental	Drug: AZR-MD-001 High DoseAZR-MD-001 High Dose will be dosed up to once daily.
AZR-MD-001 Vehicle	Sham comparator	Drug: AZR-MD-001 VehicleAZR-MD-001 Vehicle will be dosed up to once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZR-MD-001 Low DoseAZR-MD-001 is an ophthalmic ointment	Drug	AZR-MD-001 Low Dose
AZR-MD-001 Mid DoseAZR-MD-001 is an ophthalmic ointment	Drug	AZR-MD-001 Mid Dose
AZR-MD-001 High DoseAZR-MD-001 is an ophthalmic ointment	Drug	AZR-MD-001 High Dose
AZR-MD-001 VehicleAZR-MD-001 is a vehicle ophthalmic ointment	Drug	AZR-MD-001 Vehicle

Primary outcome

Meibomian Glands Yielding Liquid Secretion (MGYLS)
Time frame: Value at month 3 minus value at baseline
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Ocular Surface Disease Index (OSDI) Total Score
Time frame: Value at month 3 minus value at baseline
Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)

Results and safety

Results posted to the registry on 28 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZR-MD-001 Low Dose	9	9
AZR-MD-001 Mid Dose	27	22
AZR-MD-001 High Dose	24	16
AZR-MD-001 Vehicle	16	15

Primary outcome: Meibomian Glands Yielding Liquid Secretion (MGYLS)

Time frame: Value at month 3 minus value at baseline. Mean (Standard Deviation). Unit: Number of Open Glands

Measure	Stage 1: AZR-MD-001 Low Dose n = 9	Stage 1: AZR-MD-001 Mid Dose n = 27	Stage 1: AZR-MD-001 High Dose n = 24	Stage 1: AZR-MD-001 Vehicle n = 16	Stage 2: AZR-MD-001 Mid Dose n = 82	Stage 2: AZR-MD-001 High Dose n = 83	Stage 2: AZR-MD-001 Vehicle n = 80
Value	-0.7 (1.56)	3.41 (0.8)	3.07 (0.81)	1.88 (1.38)	4.2 (0.36)	3.2 (0.4)	2.4 (0.34)

Primary outcome: Ocular Surface Disease Index (OSDI) Total Score

Time frame: Value at month 3 minus value at baseline. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Stage 1: AZR-MD-001 Low Dose n = 9	Stage 1: AZR-MD-001 Mid Dose n = 27	Stage 1: AZR-MD-001 High Dose n = 24	Stage 1: AZR-MD-001 Vehicle n = 16	Stage 2: AZR-MD-001 Mid Dose n = 82	Stage 2: AZR-MD-001 High Dose n = 83	Stage 2: AZR-MD-001 Vehicle n = 80
Value	12.93 (4.62)	-8.73 (2.37)	-4.74 (2.41)	-2.34 (4.09)	-7.29 (1.3)	-6.1 (1.3)	-3.8 (1.2)

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: AZR-MD-001 Low Dose	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Stage 1: AZR-MD-001 Mid Dose	0 of 27 (0%)	13 of 27 (48.1%)	0 of 27
Stage 1: AZR-MD-001 High Dose	2 of 24 (8.3%)	14 of 24 (58.3%)	0 of 24
Stage 1: AZR-MD-001 Vehicle	0 of 16 (0%)	4 of 16 (25%)	0 of 16
Stage 2: AZR-MD-001 Mid Dose	1 of 82 (1.2%)	54 of 82 (65.9%)	0 of 82
Stage 2: AZR-MD-001 High Dose	1 of 83 (1.2%)	60 of 83 (72.3%)	0 of 83
Stage 2: AZR-MD-001 Vehicle	2 of 80 (2.5%)	8 of 80 (10%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37478969Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.
Individual participant dataSharing planned: No

Related trials for Meibomian Gland Dysfunction

Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
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Not yet recruiting
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie L Watson principal investigator

Save Sight Institute

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose and AZR-MD-001 High Dose in people with Meibomian Gland Dysfunction and Dry Eye, run by Azura Ophthalmics at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Meibomian Glands Yielding Liquid Secretion (MGYLS) (time frame: Value at month 3 minus value at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03652051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.