Contact Lens Discomfort (CLD), Meibomian Gland Dysfunction (MGD)
Conditions
Brief 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).
Detailed 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).
Interventions
AZR-MD-001 is an ophthalmic ointment
DRUGAZR-MD-001 Active Dose
AZR-MD-001 is an ophthalmic ointment
Sponsors
The University of New South Wales
Azura Ophthalmics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS). | Month 4 | 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. |
| Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). | Month 4 | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZR-MD-001 Vehicle AZR-MD-001 Vehicle will be dosed up to once daily.
AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment | 9 |
| AZR-MD-001 Active Dose AZR-MD-001 Active Dose will be dosed up to once daily.
AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment | 17 |
| Total | 26 |
Baseline characteristics
| Characteristic | AZR-MD-001 Vehicle | Total | AZR-MD-001 Active Dose |
|---|---|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 19.2 | 32.1 years STANDARD_DEVIATION 14.7 | 21.4 years STANDARD_DEVIATION 32.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 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 | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Australia | 9 participants | 26 participants | 17 participants |
| Sex: Female, Male Female | 5 Participants | 19 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 13 |
| other Total, other adverse events | 0 / 7 | 3 / 13 |
| serious Total, serious adverse events | 0 / 7 | 0 / 13 |
Outcome results
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.
Time frame: Month 4
Population: Modified Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZR-MD-001 Vehicle | Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). | 3.9 Units on the MGYLS scale | Standard Deviation 3.2 |
| AZR-MD-001 Active Dose | Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). | 4.1 Units on the MGYLS scale | Standard Deviation 4.4 |
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.
Time frame: Month 4
Population: Modified Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZR-MD-001 Vehicle | Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS). | 12.1 Units on the Meibomian Gland Score scale | Standard Deviation 10.7 |
| AZR-MD-001 Active Dose | Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS). | 16 Units on the Meibomian Gland Score scale | Standard Deviation 11.3 |