NCT04391959

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

Completed Phase 2 Results posted Last updated 16 May 2022

What this trial tests

Phase 2 trial testing AZR-MD-001 Active in Meibomian Gland Dysfunction in 31 participants. Completed in 6 January 2021.

Timeline

17 July 2020

Primary endpoint
6 January 2021

6 January 2021

Quick facts

Lead sponsor	Azura Ophthalmics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	17 July 2020
Primary completion	6 January 2021
Estimated completion	6 January 2021
Sites	5 locations across New Zealand, Australia

Drugs / interventions tested

• AZR-MD-001 Active
• AZR-MD-001 Vehicle — full drug profile →

Conditions studied

• Meibomian Gland Dysfunction — all drugs for Meibomian Gland Dysfunction →

Sponsor

Azura Ophthalmics — full company profile →

Who can join

18 and older, any sex, with Meibomian Gland Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Meibum Gland Secretion Score (MGS) Primary · Month 3

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

Group	Value	95% CI
AZR-MD-001 Vehicle	0.5	± 1.83
AZR-MD-001 Active	7.4	± 1.53

Total OSDI Secondary · Day 14 to Month 3

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

Group	Value	95% CI
AZR-MD-001 Vehicle	-2.0	± 3.49
AZR-MD-001 Active	-8.1	± 2.86

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AZR-MD-001 Vehicle

Serious: 0/16 (0%)

Deaths: 0/16

AZR-MD-001 Active

Serious: 1/15 (7%)

Deaths: 1/15

Serious adverse events (1 terms)

Reaction	System	AZR-MD-001 Vehicle	AZR-MD-001 Active
dysuria	Renal and urinary disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	AZR-MD-001 Vehicle	AZR-MD-001 Active
Eye pain	Eye disorders	—	—
Eye irritation	Eye disorders	—	—
Eye pruritus	Eye disorders	—	—
Ocular discomfort	Eye disorders	—	—
Vision blurred	Eye disorders	—	—
Conjunctival hyperaemia	Eye disorders	—	—
Dry eye	Eye disorders	—	—
Foreign body sensation	Eye disorders	—	—
Photophobia	Eye disorders	—	—

Most-reported serious reactions: dysuria.

Data from ClinicalTrials.gov NCT04391959 adverse events section.

Sponsor's own description

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.