An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

NCT ID: NCT03972501

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2020-12-11

Brief Summary

SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

Detailed Description

SOVS2019-070 is a single-center, single-masked (the individual(s) performing efficacy measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized, parallel group study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

Conditions

Meibomian Gland Dysfunction (MGD); Contact Lens Discomfort (CLD)

Study Design

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

Study Groups

AZR-MD-001 Vehicle

AZR-MD-001 Vehicle will be dosed up to once daily.

Group Type: PLACEBO_COMPARATOR

AZR-MD-001 Vehicle

Intervention Type: DRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Active Dose

AZR-MD-001 Active Dose will be dosed up to once daily.

Group Type: EXPERIMENTAL

AZR-MD-001 Active Dose

Intervention Type: DRUG

AZR-MD-001 is an ophthalmic ointment

Interventions

AZR-MD-001 Vehicle

AZR-MD-001 is an ophthalmic ointment

Intervention Type: DRUG

AZR-MD-001 Active Dose

AZR-MD-001 is an ophthalmic ointment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• MGD Patients:

• 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
• TBUT < 10 seconds in both eyes
• CLD Patients:

• 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
• A history of wearing soft contact lenses for at least 6 months
• Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.
• Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"
• Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.
• Baseline CLDEQ-8 score >12
• Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing.

Exclusion Criteria

• Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease
• Patient has glaucoma or ocular hypertension
• Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
• BCVA worse than 20/40 in either eye at the baseline visit

• 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

School of Optometry and Vision Science, University of New South Wales

Sydney, New South Wales, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOVS2019-070

Identifier Type: -

Identifier Source: org_study_id