Meibomian Gland DysfunctionPhase 2NCT04391959
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
A Phase 2 study testing AZR-MD-001 Active in people with Meibomian Gland Dysfunction, run by Azura Ophthalmics at 5 sites in 2 countries.
Trial summary
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- AZR-MD-001 Active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 17 Jul 2020to 6 Jan 2021
- 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
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
Scott A Read
Brisbane, Queensland
Susan Thackwray
Maroochydore, Queensland
Fiona Stapleton
Sydney, New South Wales
About this study
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)
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
Read the 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)
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- AZR-MD-001 Active, AZR-MD-001 Vehicle
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZR-MD-001 ActiveDrug
Also called AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 is an active ophthalmic ointment
AZR-MD-001 VehicleDrug
Also called AZR-MD-001 Vehicle is an ophthalmic ointment
AZR-MD-001 is a vehicle ophthalmic ointment
| Study group | Role | What they receive |
|---|---|---|
| AZR-MD-001 Vehicle | Experimental | AZR-MD-001 Vehicle will be dosed up to twice weekly. Receives: Drug: AZR-MD-001 Vehicle |
| AZR-MD-001 Active | Experimental | AZR-MD-001 Active will be dosed up to twice weekly. Receives: Drug: AZR-MD-001 Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibum Gland Secretion Score (MGS)
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.
Measured: Month 3
Secondary outcomes (1)
Total OSDI
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.
Measured: Day 14 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start17 Jul 2020
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azura Ophthalmics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Jacqueline Tan-Showyin, Principal investigator, School of Optometry and Vision Science, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391959
- Sponsor's protocol ID
- AZ202001
- Status last verified
- Jan 2021
- First submitted
- 13 May 2020
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. 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 and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
- ClinicalTrials.gov ID
- NCT04391959
- Acronym / sponsor ID
- AZ202001
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Azura OphthalmicsIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZR-MD-001 Vehicle | Experimental | Drug: AZR-MD-001 VehicleAZR-MD-001 Vehicle will be dosed up to twice weekly. |
| AZR-MD-001 Active | Experimental | Drug: AZR-MD-001 ActiveAZR-MD-001 Active will be dosed up to twice weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 ActiveAlso: AZR-MD-001 is an ophthalmic ointmentAZR-MD-001 is an active ophthalmic ointment | Drug | AZR-MD-001 Active |
| AZR-MD-001 VehicleAlso: AZR-MD-001 Vehicle is an ophthalmic ointmentAZR-MD-001 is a vehicle ophthalmic ointment | Drug | AZR-MD-001 Vehicle |
Primary outcome
Meibum Gland Secretion Score (MGS)
Time frame: 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.
1 secondary outcome
Total OSDI
Time frame: Day 14 to Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Meibomian Gland Dysfunction
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
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.
Jacqueline Tan-Showyin principal investigator
School of Optometry and Vision Science, University of New South Wales
5 sites in 2 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 Active in people with Meibomian Gland Dysfunction, run by Azura Ophthalmics at 5 sites in 2 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 5 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 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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. 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 16 May 2022). 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?
Meibum Gland Secretion Score (MGS) (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2022.