Phase 2
Completed N=31
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Source: ClinicalTrials.gov NCT04391959 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
May 2022
Primary outcomePrimary: Meibum Gland Secretion Score (MGS) — 0.5; 7.4 score on a scale
Summary
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Meibum Gland Secretion Score (MGS) |
0.5; 7.4 | — |
| SECONDARY Total OSDI |
-2.0; -8.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04391959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.