Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Phase 2

Completed

Brief Summary: Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

Detailed Description: Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Recruitment & Eligibility

Inclusion Criteria

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:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes

Exclusion Criteria

Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity
Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
Contact lens use anticipated during the study

Arm && Interventions

Group	Intervention	Description
AZR-MD-001 Active + Conventional Treatment	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®
AZR-MD-001 vehicle	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 vehicle control
AZR-MD-001 Active	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 ointment/semi-solid drug (1.0%)

Primary Outcome Measures

Name	Time	Method
Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)	Month 3	The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012) Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.

Secondary Outcome Measures