The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
depot intracameral
Prednisolone eye drops 1%
Kislinger MD inc
Glendora, California, United States
Inland Eye Specialists
Hemet, California, United States
Harvard Eye Associated
Laguna Hills, California, United States
Feinerman Vision Center
Newport Beach, California, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Associated Eye Care
Stillwater, Minnesota, United States
Matossian Eye Associates
Pennington, New Jersey, United States
Ophthalmic Consultants of Long Island
Garden City, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Carolina Eye Care Physicians
Mt. Pleasant, South Carolina, United States
...and 1 more locations
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Time frame: Baseline to postoperative day 90/ early termination
Intraocular Pressure Measurement
Intraocular Pressure was measured by Goldmann applanation tonometry.
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Visual Acuity in Study Eye
Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Slit Lamp Biomicroscopy - Cornea Edema Grade
Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Changes in the Corneal Endothelial Cell Count
Corneal Endothelial Cell Density was measured by specular microscopy.
Time frame: Baseline, Postoperative day 90/Early termination
Optic Disc Cup-disc Ratio for the Study Eye
Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Retina (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Macula (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Time frame: Baseline, POD 90/Early termination
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Time frame: Baseline, POD 90/Early termination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.