An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

• Status: Completed
• Trial end date: 2020-12-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azura Ophthalmics
• Collaborator: The University of New South Wales

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 < 10 seconds in both eyes

• CLD 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

• A history of wearing soft contact lenses for at least 6 months

• Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.

• Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"

• Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.

• Baseline CLDEQ-8 score >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