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

Azura Ophthalmics

Status and phase

Completed

Phase 2

Conditions

Meibomian Gland Dysfunction (MGD)

Contact Lens Discomfort (CLD)

Treatments

Drug: AZR-MD-001 Vehicle

Drug: AZR-MD-001 Active Dose

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03972501

SOVS2019-070

Details and patient eligibility

About

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).

Full 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).

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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