Meibomian Gland Dysfunction
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
Interventions
DRUGAGN-195263 0.1%
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
DRUGAGN-195263 0.03%
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
DRUGAGN-195263 0.01%
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
DRUGAGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meibomian gland dysfunction in both eyes * Best-corrected visual acuity of 20/40 or better in each eye
Exclusion criteria
* Known or suspected prostate cancer * History of breast cancer * Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study * Contact lens wear in either eye during any portion of the study * Unable to instill eye drops correctly * History of corneal refractive surgery in either eye within 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Meibum Quality Responders in the Study Eye | Month 6 | Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye | Month 6 | The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit. |
| Percentage of Complete Overall Ocular Discomfort Responders | Month 6 | Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit. |
Countries
United States
Participant flow
Pre-assignment details
Patients from one site were excluded from the modified intent-to-treat analysis population due to compliance issues. Patients from this site who received study treatment were included in the safety population and are reflected in the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| AGN-195263 0.1% 1 drop of AGN-195263 0.1% instilled in each eye twice daily. | 57 |
| AGN-195263 0.03% 1 drop of AGN-195263 0.03% instilled in each eye twice daily. | 58 |
| AGN-195263 0.01% 1 drop of AGN-195263 0.01% instilled in each eye twice daily. | 59 |
| AGN-195263 Vehicle 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. | 58 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 3 | 3 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 0 |
| Overall Study | Other Reasons | 0 | 2 | 3 | 7 |
| Overall Study | Personal Reasons | 3 | 1 | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | AGN-195263 0.1% | AGN-195263 0.03% | AGN-195263 0.01% | AGN-195263 Vehicle | Total |
|---|---|---|---|---|---|
| Age, Customized 40 year to less than 55 years | 17 participants | 17 participants | 20 participants | 19 participants | 73 participants |
| Age, Customized 55 years to 65 years | 26 participants | 24 participants | 19 participants | 18 participants | 87 participants |
| Age, Customized over 65 years | 14 participants | 17 participants | 20 participants | 21 participants | 72 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 39 Participants | 39 Participants | 156 Participants |
| Sex: Female, Male Male | 18 Participants | 19 Participants | 20 Participants | 19 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 57 | 6 / 58 | 3 / 59 | 7 / 58 |
| serious Total, serious adverse events | 1 / 57 | 4 / 58 | 3 / 59 | 0 / 58 |
Outcome results
Primary
Percentage of Meibum Quality Responders in the Study Eye
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
Time frame: Month 6
Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-195263 0.1% | Percentage of Meibum Quality Responders in the Study Eye | 46.3 Percentage of Patients |
| AGN-195263 0.03% | Percentage of Meibum Quality Responders in the Study Eye | 33.9 Percentage of Patients |
| AGN-195263 0.01% | Percentage of Meibum Quality Responders in the Study Eye | 32.1 Percentage of Patients |
| AGN-195263 Vehicle | Percentage of Meibum Quality Responders in the Study Eye | 42.9 Percentage of Patients |
Secondary
Percentage of Complete Overall Ocular Discomfort Responders
Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.
Time frame: Month 6
Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-195263 0.1% | Percentage of Complete Overall Ocular Discomfort Responders | 20.0 Percentage of Patients |
| AGN-195263 0.03% | Percentage of Complete Overall Ocular Discomfort Responders | 19.6 Percentage of Patients |
| AGN-195263 0.01% | Percentage of Complete Overall Ocular Discomfort Responders | 14.8 Percentage of Patients |
| AGN-195263 Vehicle | Percentage of Complete Overall Ocular Discomfort Responders | 9.8 Percentage of Patients |
Secondary
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.
Time frame: Month 6
Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-195263 0.1% | Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye | 20.4 Percentage of Patients |
| AGN-195263 0.03% | Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye | 23.2 Percentage of Patients |
| AGN-195263 0.01% | Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye | 15.1 Percentage of Patients |
| AGN-195263 Vehicle | Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye | 22.4 Percentage of Patients |