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

Sponsor
Azura Ophthalmics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03652051
Collaborator
Syneos Health (Other), Cliantha Research (Other)
136
Enrollment
15
Locations
4
Arms
38.7
Anticipated Duration (Months)
9.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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)

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 10, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/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

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)

  2. Meibomian Glands Yielding Liquid Secretion (MGYLS) [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) [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) [Day 14, Month 1, Month 1.5]

    Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)

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

SiteCityStateCountryPostal Code
1Vision Eye InstituteChatswoodNew South WalesAustralia2067
2Eye AssociatesSydneyNew South WalesAustralia2000
3Sydney Eye HospitalSydneyNew South WalesAustralia2000
4School of Optometry and Vision Science, University of New South WalesSydneyNew South WalesAustralia2052
5Queensland University of TechnologyBrisbaneQueenslandAustralia4059
6Queensland Eye InstituteSouth BrisbaneQueenslandAustralia4101
7Ophthalmic Trials AustraliaTeneriffeQueenslandAustralia4005
8Eye Laser SpecialistsArmadaleVictoriaAustralia3143
9Bendigo Eye ClinicBendigoVictoriaAustralia3550
10Waverley Eye ClinicGlen WaverleyVictoriaAustralia3150
11Downie Laboratory, Department of Optometry and Vision SciencesMelbourneVictoriaAustralia3053
12Deakin UniversityWaurn PondsVictoriaAustralia3216
13Cliantha ResearchMississaugaOntarioCanadaL4W 1A4
14University of AucklandAucklandNew Zealand1023
15AucklandEyeAucklandNew Zealand1050

Sponsors and Collaborators

  • Azura Ophthalmics
  • Syneos Health
  • Cliantha Research

Investigators

  • Principal Investigator: Stephanie L Watson, Save Sight Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Azura Ophthalmics
ClinicalTrials.gov Identifier:
NCT03652051
Other Study ID Numbers:
  • AZ201801
First Posted:
Aug 29, 2018
Last Update Posted:
Oct 22, 2021
Last Verified:
Jul 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:

Study Results

No Results Posted as of Oct 22, 2021