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

Meibomian Gland Dysfunction Clinical Trial

Official title:

A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314362
• Other study ID #: SOVS2020-080
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 14, 2020
• Est. completion date: January 6, 2021

Study information

• Verified date: March 2020
• Source: Azura Ophthalmics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• AZR-MD-001 ointment/semi-solid drug
AZR-MD-001 (1.0%) and suitable excipient

Locations

Country	Name	City	State
Australia	Fiona Stapleton	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Azura Ophthalmics	The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)	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.	Month 3