SURF-200 is being studied in people experiencing an episodic flare-up of their dry eye disease. SURF-200 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop. The purpose of this research study is to see how well SURF-200 works and what side effects there are, and to compare it with vehicle (placebo). The study will involve about 120 study participants at multiple research sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
topical corticosteroid solution
topical corticosteroid solution
topical vehicle solution
Trinity Research Group
Dothan, Alabama, United States
Canyon City EyeCare
Azusa, California, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Visionary Eye Institute
Newport Beach, California, United States
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Time frame: Baseline and Day 8
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Time frame: Baseline and Day 15
Conjunctival Hyperemia Responder Analysis
Conjunctival hyperemia was graded by Investigator using the scale below and clinical grade reference photos: Grade 0 (none: no hyperemia of the bulbar conjunctiva) Grade 0.5 (Grade 0 plus dilation of at least a couple of conjunctival blood vessels \[CBVs\] but less than Grade 1) Grade 1 (mild: the dilation of a few CBVs) Grade 1.5 (Grade 1 plus dilation of some CBVs but less than Grade 2) Grade 2 (moderate: the dilation of several CBVs) Grade 2.5 (Grade 2 plus dilation of many CBVs but less than Grade 3) Grade 3 (severe: the abundant and overwhelming dilation of many CBVs) Participants with a minimum reduction of ≥0.5 point in conjunctival hyperemia grade in the study eye from baseline were defined as responders, and response rates were summarized by treatment group.
Time frame: Baseline and Day 8
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North Bay Eye Associates
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Vision Institute
Colorado Springs, Colorado, United States
The Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Connecticut Eye Consultants, PC
Danbury, Connecticut, United States
...and 18 more locations