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

NCT ID: NCT04314362

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2021-01-06

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.

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AZR-MD-001 Active

AZR-MD-001 ointment/semi-solid drug (1.0%)

Group Type: EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug

Intervention Type: DRUG

AZR-MD-001 (1.0%) and suitable excipient

AZR-MD-001 Active + Conventional Treatment

AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®

Group Type: EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug

Intervention Type: DRUG

AZR-MD-001 (1.0%) and suitable excipient

AZR-MD-001 vehicle

AZR-MD-001 vehicle control

Group Type: EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug

Intervention Type: DRUG

AZR-MD-001 (1.0%) and suitable excipient

Interventions

AZR-MD-001 ointment/semi-solid drug

AZR-MD-001 (1.0%) and suitable excipient

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: collaborator

Azura Ophthalmics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fiona Stapleton

Sydney, New South Wales, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOVS2020-080

Identifier Type: -

Identifier Source: org_study_id