Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=31 Randomized Triple-blind Treatment

Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

Meibomian Gland Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT04391959 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
May 2022
Primary outcome: Primary: Meibum Gland Secretion Score (MGS) — 0.5; 7.4 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
AZR-MD-001 Active (Drug); AZR-MD-001 Vehicle (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Azura Ophthalmics
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Meibum Gland Secretion Score (MGS)		 0.5; 7.4 —
SECONDARY
Total OSDI		 -2.0; -8.1 —

Summary

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

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 (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.

Back to search