Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
- Registration Number
- NCT02547623
- Lead Sponsor
- ICON Bioscience Inc
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
- undergoing cataract surgery
- glaucoma patient, pregnancy, allergy to dexamethasone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexamethasone depot Dexamethasone dexamethasone depot 517 mcg standard of care Prednisolone prednisolone drops 1%
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Baseline to postoperative day 90/ early termination 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.
- Secondary Outcome Measures
Name Time Method Intraocular Pressure Measurement Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination Intraocular Pressure was measured by Goldmann applanation tonometry.
Visual Acuity in Study Eye Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination 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
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination 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.Slit Lamp Biomicroscopy - Cornea Edema Grade Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination 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.Summary of Concomitant Medications Used in the Study Eye or Both Eyes Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination Changes in the Corneal Endothelial Cell Count Baseline, Postoperative day 90/Early termination Corneal Endothelial Cell Density was measured by specular microscopy.
Optic Disc Cup-disc Ratio for the Study Eye Baseline, POD 90/Early termination Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye) Baseline, POD 90/Early termination The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Dilated Opthalmoscopy Findings - Retina (Study Eye) Baseline, POD 90/Early termination The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Dilated Opthalmoscopy Findings - Macula (Study Eye) Baseline, POD 90/Early termination The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Dilated Opthalmoscopy Findings - Choroid (Study Eye) Baseline, POD 90/Early termination The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Dilated Opthalmoscopy Findings - Vitreous (Study Eye) Baseline, POD 90/Early termination The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Trial Locations
- Locations (10)
Inland Eye Specialists
🇺🇸Hemet, California, United States
Kislinger MD inc
🇺🇸Glendora, California, United States
Harvard Eye Associated
🇺🇸Laguna Hills, California, United States
Feinerman Vision Center
🇺🇸Newport Beach, California, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Matossian Eye Associates
🇺🇸Pennington, New Jersey, United States
Associated Eye Care
🇺🇸Stillwater, Minnesota, United States
Ophthalmic Consultants of Long Island
🇺🇸Garden City, New York, United States
the eye institute of Utah
🇺🇸Salt Lake City, Utah, United States
Carolina Eye Care Physicians
🇺🇸Mount Pleasant, South Carolina, United States