A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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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.

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: AGN-195263 0.1%
* Drug: AGN-195263 0.03%
* Drug: AGN-195263 0.01%
* Drug: AGN-195263 Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-195263 0.1%<br>1 drop of AGN-195263 0.1% instilled in each eye twice daily. | Drug: AGN-195263 0.1%<br>* 1 drop of AGN-195263 0.1% instilled in each eye twice daily.<br>|
| Experimental: AGN-195263 0.03%<br>1 drop of AGN-195263 0.03% instilled in each eye twice daily. | Drug: AGN-195263 0.03%<br>* 1 drop of AGN-195263 0.03% instilled in each eye twice daily.<br>|
| Experimental: AGN-195263 0.01%<br>1 drop of AGN-195263 0.01% instilled in each eye twice daily. | Drug: AGN-195263 0.01%<br>* 1 drop of AGN-195263 0.01% instilled in each eye twice daily.<br>|
| Placebo Comparator: AGN-195263 Vehicle<br>1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. | Drug: AGN-195263 Vehicle<br>* 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |