This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
232
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Cornea Consultants of Arizona
Phoenix, Arizona, United States
University of Arkansas for Medical
Little Rock, Arkansas, United States
Sall Research Medical Center
Artesia, California, United States
Orange County Ophthalmology Medical Group, Inc.
Garden Grove, California, United States
Lugene Eye Institute
Glendale, California, United States
Lakeside Vision Center
Irvine, California, United States
Scripps Clinic
La Jolla, California, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
...and 23 more locations