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Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZR-MD-001 Active
AZR-MD-001 Vehicle
Sponsored by
Azura Ophthalmics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fiona Stapleton
  • Scott A Read
  • Susan Thackwray
  • Jagrut Lallu
  • Jennifer P Craig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AZR-MD-001 Vehicle

AZR-MD-001 Active

Arm Description

AZR-MD-001 Vehicle will be dosed up to twice weekly.

AZR-MD-001 Active will be dosed up to twice weekly.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 13, 2020
Last Updated
March 1, 2022
Sponsor
Azura Ophthalmics
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT04391959
Brief Title
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azura Ophthalmics
Collaborators
Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZR-MD-001 Vehicle
Arm Type
Experimental
Arm Description
AZR-MD-001 Vehicle will be dosed up to twice weekly.
Arm Title
AZR-MD-001 Active
Arm Type
Experimental
Arm Description
AZR-MD-001 Active will be dosed up to twice weekly.
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 Active
Other Intervention Name(s)
AZR-MD-001 is an ophthalmic ointment
Intervention Description
AZR-MD-001 is an active ophthalmic ointment
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 Vehicle
Other Intervention Name(s)
AZR-MD-001 Vehicle is an ophthalmic ointment
Intervention Description
AZR-MD-001 is a vehicle ophthalmic ointment
Primary Outcome Measure Information:
Title
Meibum Gland Secretion Score (MGS)
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Total OSDI
Description
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.
Time Frame
Day 14 to Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Tan-Showyin
Organizational Affiliation
School of Optometry and Vision Science, University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fiona Stapleton
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Scott A Read
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Susan Thackwray
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
Jagrut Lallu
City
Auckland
Country
New Zealand
Facility Name
Jennifer P Craig
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

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