Phase 3
N=32
Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Meibomian Gland Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04314362 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) — 12.8; 8.8 Units on the MGS Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AZR-MD-001 ointment/semi-solid drug (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azura Ophthalmics
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) |
12.8; 8.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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:
Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes
Exclusion Criteria
- Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
- Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity
- Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
- Contact lens use anticipated during the study
Data sourced from ClinicalTrials.gov (NCT04314362). 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.