Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

Meibomian Gland Dysfunction Clinical Trial

Official title:

A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391959
• Other study ID #: AZ202001
• Status: Completed
• Phase: Phase 2
• Start date: July 17, 2020
• Est. completion date: January 6, 2021

Study information

• Verified date: January 2021
• Source: Azura Ophthalmics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Description:

AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• 18 years of age or older

• Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye

• Evidence of meibomian gland obstruction

• Reported dry eye signs and symptoms within the past 3 months

Exclusion Criteria:

• Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease

• Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening =24 mm Hg 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 or corneal integrity

• BCVA worse than 20/40 in either eye

• Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• AZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment
• AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment

Locations

Country	Name	City	State
Australia	Scott A Read	Brisbane	Queensland
Australia	Susan Thackwray	Maroochydore	Queensland
Australia	Fiona Stapleton	Sydney	New South Wales
New Zealand	Jagrut Lallu	Auckland
New Zealand	Jennifer P Craig	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Azura Ophthalmics	Avania

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibum Gland Secretion Score (MGS)	Change from Baseline in 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 will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: 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 3
Secondary	Total OSDI	Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: ([sum of scores for all questions answereda] X 100)/([total number of questions answered] X 4).; Questions answered with N/A were excluded in the calculation of total OSDI.	Day 14 to Month 3