Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing cataract surgery Exclusion Criteria: glaucoma patient, pregnancy, allergy to dexamethasone

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone depot<br>dexamethasone depot 517 mcg | Drug: Dexamethasone<br>* depot intracameral<br>* Other names: Dexycu;|
| Active Comparator: standard of care<br>prednisolone drops 1% | Drug: Prednisolone<br>* Prednisolone eye drops 1%<br>* Other names: standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to postoperative day 90/ early termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure Measurement | Intraocular Pressure was measured by Goldmann applanation tonometry. | 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 | 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. | 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. | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | 
| 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 | Corneal Endothelial Cell Density was measured by specular microscopy. | 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). | 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 | 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 | 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. | 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 | 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 | Baseline, POD 90/Early termination |