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This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-195263 0.1% | Experimental | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. |
|
| AGN-195263 0.03% | Experimental | 1 drop of AGN-195263 0.03% instilled in each eye twice daily. |
|
| AGN-195263 0.01% | Experimental | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. |
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| AGN-195263 Vehicle | Placebo Comparator | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-195263 0.1% | Drug | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| University of Arkansas for Medical |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-195263 0.1% | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. |
| FG001 | AGN-195263 0.03% | 1 drop of AGN-195263 0.03% instilled in each eye twice daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AGN-195263 0.03% |
| Drug |
1 drop of AGN-195263 0.03% instilled in each eye twice daily. |
|
| AGN-195263 0.01% | Drug | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. |
|
| AGN-195263 Vehicle | Drug | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
|
| Month 6 |
| 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. | Month 6 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Sall Research Medical Center | Artesia | California | 90701 | United States |
| Orange County Ophthalmology Medical Group, Inc. | Garden Grove | California | 92843 | United States |
| Lugene Eye Institute | Glendale | California | 91205 | United States |
| Lakeside Vision Center | Irvine | California | 92604 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| North Valley Eye Medical Group, Inc. | Mission Hills | California | 91345 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Centennial Eye Associates | Centennial | Colorado | 80112 | United States |
| Colorado Eye Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| Danbury Eye Physicians & Surgeons, PC | Danbury | Connecticut | 06810 | United States |
| The Eye Associates of Manatee, LLP | Bradenton | Florida | 34209 | United States |
| Wohl Eye Center | Bloomingdale | Illinois | 60108 | United States |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | United States |
| Durrie Vision | Overland Park | Kansas | 66061 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Northern New Jersey Eye Institute, PA | South Orange | New Jersey | 07079 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Ophthalmic Consultants Long Island | Rockville Centre | New York | 11570 | United States |
| South Shore Eye Care, LLP | Wantagh | New York | 11793 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Drs. Fine, Hoffman, and Packer, LLC | Eugene | Oregon | 97401 | United States |
| Vision Center of Texas, PA | Cedar Park | Texas | 78613 | United States |
| University of Houston, College of Optometry | Houston | Texas | 77204 | United States |
| Focus Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Stacy Smith, MD, PC | Salt Lake City | Utah | 84117 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| FG002 | AGN-195263 0.01% | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. |
| FG003 | AGN-195263 Vehicle | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-195263 0.1% | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. |
| BG001 | AGN-195263 0.03% | 1 drop of AGN-195263 0.03% instilled in each eye twice daily. |
| BG002 | AGN-195263 0.01% | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. |
| BG003 | AGN-195263 Vehicle | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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 | Posted | Number | Percentage of Patients | Month 6 |
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| 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. | 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 | Posted | Number | Percentage of Patients | Month 6 |
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| 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. | 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 | Posted | Number | Percentage of Patients | Month 6 |
|
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The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN-195263 0.1% | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. | 1 | 57 | 7 | 57 | ||
| EG001 | AGN-195263 0.03% | 1 drop of AGN-195263 0.03% instilled in each eye twice daily. | 4 | 58 | 6 | 58 | ||
| EG002 | AGN-195263 0.01% | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. | 3 | 59 | 3 | 59 | ||
| EG003 | AGN-195263 Vehicle | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. | 0 | 58 | 7 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA version 17.1 | Systematic Assessment | Males Only |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Bradford | Allergan plc | 1-714-846-5486 | Bradford_Ron@allergan.com |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| 55 years to 65 years |
|
| over 65 years |
|
| Male |
|
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
| OG003 | AGN-195263 Vehicle | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
|
|
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
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