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

NCT03972501 | Completed Phase 2 Results

• 1 other identifier: SOVS2019-070
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum 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 methods published by 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 4

• Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).

  The MGYLS can range from 0 (highly abnormal) to 15 (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. The number of glands secreting any liquid were counted using the methods published by 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 4

Study Arms (2)

AZR-MD-001 Vehicle

PLACEBO COMPARATOR

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

Drug: AZR-MD-001 Vehicle

AZR-MD-001 Active Dose

EXPERIMENTAL

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

Drug: AZR-MD-001 Active Dose

Interventions

AZR-MD-001 Vehicle DRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Vehicle

AZR-MD-001 Active Dose DRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Active Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azura Ophthalmics: lead
• The University of New South Wales: collaborator

Study Sites (1)

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

Sydney, New South Wales, 2052, Australia

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Charles Bosworth
• Organization: Azura Ophthalmics

charles.bosworth@azuraophthalmics.com

17145598435

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: October 4, 2019
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)