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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652051
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Azura Ophthalmics

Brief 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)

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Dry Eye Drug: AZR-MD-001 Low Dose Drug: AZR-MD-001 Mid Dose Drug: AZR-MD-001 High Dose Drug: AZR-MD-001 Vehicle Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AZR-MD-001 Low Dose
AZR-MD-001 Low Dose will be dosed up to once daily.
Drug: AZR-MD-001 Low Dose
AZR-MD-001 is an ophthalmic ointment

Experimental: AZR-MD-001 Mid Dose
AZR-MD-001 Mid Dose will be dosed up to once daily.
Drug: AZR-MD-001 Mid Dose
AZR-MD-001 is an ophthalmic ointment

Experimental: AZR-MD-001 High Dose
AZR-MD-001 High Dose will be dosed up to once daily.
Drug: AZR-MD-001 High Dose
AZR-MD-001 is an ophthalmic ointment

Sham Comparator: AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to once daily.
Drug: AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment




Primary Outcome Measures :
  1. 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)

  2. Meibomian Glands Yielding Liquid Secretion (MGYLS) [ Time Frame: Month 3 ]
    Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)


Secondary Outcome Measures :
  1. Meibum Gland Secretion Score (MGS) [ Time Frame: Day 14, Month 1, Month 1.5 ]
    Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)

  2. Meibomian Glands Yielding Liquid Secretion (MGYLS) [ Time Frame: Day 14, Month 1, Month 1.5 ]
    Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652051


Contacts
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Contact: Charles Bosworth, PhD 714-559-8435 charles.bosworth@azuraophthalmics.com
Contact: Marc Gleeson +61 422 956 128 admin@azuraophthalmics.com

Locations
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Australia, New South Wales
Eye Associates Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Geoffrey Cohn, MD    +61 414 371 423    cohnclave@gmail.com   
Sydney Eye Hospital Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Stephanie L Watson, MD    +61 (2) 9389 0666    stephanie.watson@sydney.edu.au   
School of Optometry and Vision Science, University of New South Wales Recruiting
Sydney, New South Wales, Australia, 2052
Contact: Jackie Tan-Showlin, PhD, BOptom    +61 (02) 9385 6551    jacqueline.tan@unsw.edu.au   
Sponsors and Collaborators
Azura Ophthalmics
Syneos Health
Investigators
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Principal Investigator: Stephanie L Watson Save Sight Institute
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Responsible Party: Azura Ophthalmics
ClinicalTrials.gov Identifier: NCT03652051    
Other Study ID Numbers: AZ201801
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases