NCT04314362

Brief Summary

Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 17, 2020

Results QC Date

February 14, 2022

Last Update Submit

April 25, 2022

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (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 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 published methods from 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 3

Study Arms (3)

AZR-MD-001 Active

EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug (1.0%)

Drug: AZR-MD-001 ointment/semi-solid drug

AZR-MD-001 Active + Conventional Treatment

EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®

Drug: AZR-MD-001 ointment/semi-solid drug

AZR-MD-001 vehicle

EXPERIMENTAL

AZR-MD-001 vehicle control

Drug: AZR-MD-001 ointment/semi-solid drug

Interventions

AZR-MD-001 ointment/semi-solid drugDRUG

AZR-MD-001 (1.0%) and suitable excipient

AZR-MD-001 ActiveAZR-MD-001 Active + Conventional TreatmentAZR-MD-001 vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT \< 10 seconds in both eyes

You may not qualify if:

  • Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
  • Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity
  • Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
  • Contact lens use anticipated during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fiona Stapleton

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Results Point of Contact

Title
Charles Bosworth
Organization
Azura Ophthalmics
charles.bosworth@azuraophthalmics.com
17145598435

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

July 14, 2020

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

January 25, 2023

Results First Posted

January 25, 2023

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)