Clinical trial

A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Name

SOVS2020-080

Description

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 arms

Trial start

2020-07-14

Estimated PCD

2021-01-06

Trial end

2021-01-06

Status

Completed

Phase

Early phase I

Treatment

AZR-MD-001 ointment/semi-solid drug

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

Arms:

AZR-MD-001 Active, AZR-MD-001 Active + Conventional Treatment, AZR-MD-001 vehicle

Size

Primary endpoint

Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)

Month 3

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2023-01-25

1 organization

1 product

1 indication

Organization

Azura Ophthalmics

Product

AZR-MD-001

Indication

Meibomian Gland Dysfunction