Clinical trial NCT03972501: An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Official title: A Single-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 as Adjunctive Therapy to Conventional Therapeutic Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction (MGD)
Contact Lens Discomfort (CLD)
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: The University of New South Wales
First posted: 2019-06-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: SOVS2019-070 is a single-center, single-masked (the individual(s) performing efficacy measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized, parallel group study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

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 \< 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

Primary outcomes:
measure: Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).
timeFrame: Month 4
measure: Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Optometry and Vision Science, University of New South Wales
state: New South Wales
Study officials:
References: