A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

Azura Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Drug: AZR-MD-001 Vehicle; Drug: AZR-MD-001 Low Dose; Drug: AZR-MD-001 High Dose; Drug: AZR-MD-001 Mid Dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03652051

AZ201801

Details and patient eligibility

About

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Full description

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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321 participants in 4 patient groups

AZR-MD-001 Low Dose

Experimental group

Description:

AZR-MD-001 Low Dose will be dosed up to once daily.

Treatment:

Drug: AZR-MD-001 Low Dose

AZR-MD-001 Mid Dose

Experimental group

Description:

AZR-MD-001 Mid Dose will be dosed up to once daily.

Treatment:

Drug: AZR-MD-001 Mid Dose

AZR-MD-001 High Dose

Experimental group

Description:

AZR-MD-001 High Dose will be dosed up to once daily.

Treatment:

Drug: AZR-MD-001 High Dose

AZR-MD-001 Vehicle

Sham Comparator group

Description:

AZR-MD-001 Vehicle will be dosed up to once daily.

Treatment:

Drug: AZR-MD-001 Vehicle