Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Azura Ophthalmics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Meibomian Gland Dysfunction

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04314362

SOVS2020-080

Details and patient eligibility

About

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.

Full description

Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

AZR-MD-001 Active

Experimental group

Description:

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

Treatment:

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

AZR-MD-001 Active + Conventional Treatment

Experimental group

Description:

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

Treatment:

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

AZR-MD-001 vehicle

Experimental group

Description:

AZR-MD-001 vehicle control

Treatment:

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