NCT03652051

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

A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Azura Ophthalmics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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)

Conditions

• Meibomian Gland Dysfunction
• Dry Eye

Interventions

Type	Name	Description
DRUG	AZR-MD-001 Low Dose	AZR-MD-001 is an ophthalmic ointment
DRUG	AZR-MD-001 Mid Dose	AZR-MD-001 is an ophthalmic ointment
DRUG	AZR-MD-001 High Dose	AZR-MD-001 is an ophthalmic ointment
DRUG	AZR-MD-001 Vehicle	AZR-MD-001 is a vehicle ophthalmic ointment

Timeline

• Start date: 2018-09-10
• Primary completion: 2022-09-14
• Completion: 2022-10-19
• First posted: 2018-08-29
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

30 sites across 3 countries: Australia, Canada, New Zealand

Regulatory

• FDA-regulated drug study