Status:
COMPLETED
Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Lead Sponsor:
Azura Ophthalmics
Collaborating Sponsors:
The University of New South Wales
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 st...
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 sti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04314362
Start Date
July 14 2020
End Date
January 6 2021
Last Update
January 25 2023
Active Locations (1)
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1
Fiona Stapleton
Sydney, New South Wales, Australia