Meibomian Gland Dysfunction
Conditions
Brief summary
Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.
Detailed description
Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.
Interventions
AZR-MD-001 (1.0%) and suitable excipient
Sponsors
The University of New South Wales
Azura Ophthalmics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT \< 10 seconds in both eyes
Exclusion criteria
* Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease * Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity * Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation * Contact lens use anticipated during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) | Month 3 | 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 published methods from 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZR-MD-001 Active AZR-MD-001 ointment/semi-solid drug (1.0%)
AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient | 21 |
| AZR-MD-001 Vehicle AZR-MD-001 vehicle control
AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient | 11 |
| Total | 32 |
Baseline characteristics
| Characteristic | AZR-MD-001 Active | Total | AZR-MD-001 Vehicle |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 18.9 | 47.5 years STANDARD_DEVIATION 18.8 | 51.2 years STANDARD_DEVIATION 16.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 13 Participants | 5 Participants |
| Region of Enrollment Australia | 21 participants | 32 participants | 11 participants |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 10 |
| other Total, other adverse events | 14 / 19 | 2 / 10 |
| serious Total, serious adverse events | 0 / 19 | 0 / 10 |
Outcome results
Primary
Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian 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 published methods from 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.
Time frame: Month 3
Population: Modified Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZR-MD-001 Active | Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) | 12.8 Units on the MGS Scale | Standard Deviation 11.3 |
| AZR-MD-001 Vehicle | Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) | 8.8 Units on the MGS Scale | Standard Deviation 5.6 |