NCT04314362

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Azura Ophthalmics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 (1.0%) and suitable excipient

Timeline

• Start date: 2020-07-14
• Primary completion: 2021-01-06
• Completion: 2021-01-06
• First posted: 2020-03-19
• Last updated: 2023-01-25
• Results posted: 2023-01-25

Locations

1 site across 1 country: Australia