An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Di… (NCT03972501) | Clinical Trial Compass
CompletedPhase 2
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Australia26 participantsStarted 2019-10-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).
Timeframe: Month 4
2
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).