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Phase 2 N=76 Randomized Quadruple-blind Treatment

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

Meibomian Gland Dysfunction · Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT03652051 ↗
Enrolled (actual)
76
Serious AEs
1.9%
Results posted
Feb 2024
Primary outcome: Primary: Meibomian Glands Yielding Liquid Secretion (MGYLS) — -0.7; 3.41; 3.07; 1.88 Number of Open Glands

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
AZR-MD-001 Low Dose (Drug); AZR-MD-001 Mid Dose (Drug); AZR-MD-001 High Dose (Drug); AZR-MD-001 Vehicle (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Azura Ophthalmics
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Meibomian Glands Yielding Liquid Secretion (MGYLS)		 -0.7; 3.41; 3.07; 1.88; 4.2; 3.2 —
PRIMARY
Ocular Surface Disease Index (OSDI) Total Score		 12.93; -8.73; -4.74; -2.34; -7.29; -6.1 —

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)

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03652051). 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.

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