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

Meibomian Gland Dysfunction (MGD) Clinical Trial

Official title:

A Single-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 as Adjunctive Therapy to Conventional Therapeutic Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972501
• Other study ID #: SOVS2019-070
• Status: Completed
• Phase: Phase 2
• Start date: October 4, 2019
• Est. completion date: December 11, 2020

Study information

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

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• AZR-MD-001 Vehicle
AZR-MD-001 is an ophthalmic ointment
• AZR-MD-001 Active Dose
AZR-MD-001 is an ophthalmic ointment

Locations

Country	Name	City	State
Australia	School of Optometry and Vision Science, University of New South Wales	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 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	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