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

• Sponsor: Azura Ophthalmics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04314362
• Collaborator: The University of New South Wales (Other)
• Enrollment: 29
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Drug: AZR-MD-001 ointment/semi-solid drug	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
• Actual Study Start Date: Jul 14, 2020
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZR-MD-001 Active AZR-MD-001 ointment/semi-solid drug (1.0%)	Drug: AZR-MD-001 ointment/semi-solid drug; AZR-MD-001 (1.0%) and suitable excipient
Experimental: AZR-MD-001 Active + Conventional Treatment AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®	Drug: AZR-MD-001 ointment/semi-solid drug; AZR-MD-001 (1.0%) and suitable excipient
Experimental: AZR-MD-001 vehicle AZR-MD-001 vehicle control	Drug: AZR-MD-001 ointment/semi-solid drug; AZR-MD-001 (1.0%) and suitable excipient

Outcome Measures

Primary Outcome Measures

1. Primary efficacy for MGD: change from baseline in meibomian gland secretion score (MGS) [Day 14 to Month 3]

   The MGS can range from 0 (highly abnormal) to 45 (Normal)

2. Adverse Events [Baseline to Month 3]

   Observed rate of Adverse Events

Secondary Outcome Measures

1. Total OSDI: change from baseline in Total OSDI [Day 14 to Month 3]

   Total OSDI can range in value from 0 (Normal) to 100 (Highly Abnormal)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fiona Stapleton	Sydney	New South Wales	Australia

Sponsors and Collaborators

• Azura Ophthalmics
• The University of New South Wales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azura Ophthalmics
• ClinicalTrials.gov Identifier: NCT04314362
• Other Study ID Numbers: SOVS2020-080
• First Posted: Mar 19, 2020
• Last Update Posted: Jan 11, 2021
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

No Results Posted as of Jan 11, 2021