Meibomian Gland Dysfunction
Conditions
Brief summary
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
Detailed 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)
Interventions
DRUGAZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment
AZR-MD-001 is a vehicle ophthalmic ointment
Sponsors
Avania
Azura Ophthalmics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meibum Gland Secretion Score (MGS) | Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total OSDI | Day 14 to Month 3 | 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. |
Countries
Australia, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZR-MD-001 Vehicle AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment | 16 |
| AZR-MD-001 Active AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | AZR-MD-001 Vehicle | AZR-MD-001 Active | Total |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 13.21 | 56 years STANDARD_DEVIATION 20.74 | 57.3 years STANDARD_DEVIATION 16.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 9 Participants | 21 Participants |
| Region of Enrollment Australia | 11 participants | 9 participants | 20 participants |
| Region of Enrollment New Zealand | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 1 / 15 |
| other Total, other adverse events | 2 / 16 | 8 / 15 |
| serious Total, serious adverse events | 0 / 16 | 1 / 15 |
Outcome results
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.
Time frame: Month 3
Population: Target Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZR-MD-001 Vehicle | Meibum Gland Secretion Score (MGS) | 0.5 score on a scale | Standard Deviation 1.83 |
| AZR-MD-001 Active | Meibum Gland Secretion Score (MGS) | 7.4 score on a scale | Standard Deviation 1.53 |
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.
Time frame: Day 14 to Month 3
Population: Target Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZR-MD-001 Vehicle | Total OSDI | -2.0 score on a scale | Standard Deviation 3.49 |
| AZR-MD-001 Active | Total OSDI | -8.1 score on a scale | Standard Deviation 2.86 |