Phase 2
Completed N=26
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Meibomian Gland Dysfunction (MGD) · Contact Lens Discomfort (CLD)
Source: ClinicalTrials.gov NCT03972501 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS). — 12.1; 16 Units on the Meibomian Gland Score scale
Summary
SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS). |
12.1; 16 | — |
| PRIMARY Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). |
3.9; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- MGD Patients:
- Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
- Reported dry eye signs and symptoms within the past 3 months
- TBUT 12
- Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing.
Exclusion Criteria
- Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease
- Patient has glaucoma or ocular hypertension
- Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
- BCVA worse than 20/40 in either eye at the baseline visit
Data sourced from ClinicalTrials.gov (NCT03972501). 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.