Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery

Study Overview
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Brief Summary
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This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.

Detailed Description
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All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Official Title
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A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients

Conditions
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Inflammatory Reaction Due to Ocular Lens Prosthesis

Intervention / Treatment
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* Drug: IBI-10090


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation. Exclusion Criteria: Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening. Patients with any signs of intraocular inflammation in either eye at screening. Patients who have received any prior intravitreal injections in the study eye.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>114ug | Drug: IBI-10090<br>* Single intraocular injection<br>|
| Experimental: Dose 2<br>513ug | Drug: IBI-10090<br>* Single intraocular injection<br>|
| Experimental: Dose 3<br>684ug | Drug: IBI-10090<br>* Single intraocular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of Anterior Chamber Cells | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8. | Day 8 post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Flare (ACF) Grade | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4. | Day 90 post-treatment | 
| Conjunctival Erythema Grade | Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Day 90 post-treatment | 
| Corneal Edema Grade | Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Day 90 post-treatment | 
| Anterior Chamber Cell Grade | Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4. | Day 90 post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular inflammation cataract surgery, post cataract surgery inflammation