At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 321 enrolled
Drug / intervention
AZR-MD-001 Low Dose +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose, and 2 other interventions for Meibomian Gland Dysfunction and Dry Eye. Completed, enrolled 321 participants across 30 sites in 3 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeibomian Gland Dysfunction, Dry Eye
CountriesAustralia, Canada, New Zealand
CollaboratorsSyneos Health, Cliantha Research
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartSep 2018
Primary CompletionSep 2022
Study CompletionOct 2022
TodayJul 2026
First PostedAug 29, 2018
Enrollment StartSep 10, 2018
Primary CompletionSep 14, 2022
Study CompletionOct 19, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.8 years ago
Interventions
AZR-MD-001 Low Dosedrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Mid Dosedrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 High Dosedrug
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Vehicledrug
AZR-MD-001 is a vehicle ophthalmic ointment