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

Phase 2CompletedNCT04391959

Azura Ophthalmics31 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Meibomian Gland Dysfunction

Interventions

AZR-MD-001 ActiveDRUG

AZR-MD-001 is an active ophthalmic ointment

AZR-MD-001 VehicleDRUG

AZR-MD-001 is a vehicle ophthalmic ointment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Fiona Stapleton

Sydney, New South Wales, Australia

Scott A Read

Brisbane, Queensland, Australia

Susan Thackwray

Maroochydore, Queensland, Australia

Jagrut Lallu

Auckland, New Zealand

Jennifer P Craig

Outcomes

Primary Outcomes

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.

Time frame: Month 3

Secondary Outcomes

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.

Time frame: Day 14 to Month 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.