SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 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-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
One drop twice daily (BID) in the study eye for 16 days.
One drop twice daily (BID) in the study eye for 16 days.
Inland Eye Specialists
Hemet, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Hernando Eye Institute
Brooksville, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Alterman, Modi & Wolter
Poughkeepsie, New York, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Texan Eye Care, PA - Keystone Research, Ltd.
Austin, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen
Time frame: Day 15
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).
Time frame: Day 1
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).
Time frame: Day 8
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).
Time frame: Day 15
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).
Time frame: Day 22
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).
Time frame: Day 32
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