- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03972501
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
A Single-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 as Adjunctive Therapy to Conventional Therapeutic Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2052
- School of Optometry and Vision Science, University of New South Wales
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
MGD Patients:
- Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
- Reported dry eye signs and symptoms within the past 3 months
- TBUT < 10 seconds in both eyes
CLD Patients:
- Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
- A history of wearing soft contact lenses for at least 6 months
- Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.
- Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"
- Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.
- Baseline CLDEQ-8 score >12
- Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing.
Exclusion Criteria:
- Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease
- Patient has glaucoma or ocular hypertension
- Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
- BCVA worse than 20/40 in either eye at the baseline visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to once daily.
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AZR-MD-001 is an ophthalmic ointment
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Experimental: AZR-MD-001 Active Dose
AZR-MD-001 Active Dose will be dosed up to once daily.
|
AZR-MD-001 is an ophthalmic ointment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).
Time Frame: Month 4
|
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. |
Month 4
|
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).
Time Frame: Month 4
|
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. |
Month 4
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOVS2019-070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Meibomian Gland Dysfunction (MGD)
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Hovione Scientia LimitedCompletedMeibomian Gland Dysfunction | MGD-Meibomian Gland DysfunctionUnited States
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University of WaterlooCompletedMeibomian Gland Dysfunction (MGD)Canada
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Second Affiliated Hospital, School of Medicine,...Aier Eye Hospital, WuhanCompletedMGD-Meibomian Gland DysfunctionChina
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Barzilai Medical CenterCompletedMGD-Meibomian Gland DysfunctionIsrael
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Singapore National Eye CentreNational University, SingaporeCompleted
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Zhongnan HospitalRecruitingDry Eye | MGD-Meibomian Gland DysfunctionChina
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Johnson & Johnson Surgical Vision, Inc.CompletedCataracts | Meibomian Gland Dysfunction (MGD)United States
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Zhongnan HospitalRecruitingDry Eye | Positron-Emission Tomography | MGD-Meibomian Gland DysfunctionChina
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Shenzhen Hospital of Southern Medical UniversityUnknownDry Eye | MGD-Meibomian Gland DysfunctionChina
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Aier School of Ophthalmology, Central South UniversityUnknownMeibomian Gland Massage is Important to Delay the Development of Meibomian Gland DysfunctionChina
Clinical Trials on AZR-MD-001 Vehicle
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Azura OphthalmicsORA, Inc.Not yet recruitingDry Eye DiseaseUnited States
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Azura OphthalmicsAvaniaCompletedMeibomian Gland DysfunctionAustralia, New Zealand
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Azura OphthalmicsSyneos Health; Cliantha ResearchCompletedDry Eye | Meibomian Gland DysfunctionCanada, Australia, New Zealand
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Azura OphthalmicsThe University of New South WalesCompletedMeibomian Gland DysfunctionAustralia
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Azura OphthalmicsAvaniaCompletedContact Lens DiscomfortAustralia
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Patagonia Pharmaceuticals, LLCCompletedCongenital IchthyosisUnited States
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C. R. BardMedicon, Inc.Completed
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Cloudbreak Therapeutics, LLCCompletedPterygiumUnited States
-
Cloudbreak Therapeutics, LLCRecruitingPterygiumUnited States, China, India, Australia, New Zealand
-
Timber Pharmaceuticals Inc.Active, not recruitingIchthyosisUnited States, Canada, Germany, France, Italy