KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Study Overview
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Brief Summary
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This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.

Official Title
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Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Drug: KPI-121 1%
* Drug: Prednisolone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a candidate for routine, uncomplicated cataract surgery Exclusion Criteria: Have a post-traumatic cataract. Have suspected permanent low vision or blindness in the fellow non-study eye. Have active uveitis in either eye. Have an ocular neoplasm in either eye. Have the presence of viral, bacterial, or fungal disease in either eye. Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP

Ages Eligible for Study
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Maximum Age: 3 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPI-121 1% BID (twice daily)<br> | Drug: KPI-121 1%<br>* eye drops<br>|
| Active Comparator: Prednisolone acetate QID (four times daily)<br> | Drug: Prednisolone acetate<br>* eye drops<br>* Other names: Pred Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell Grade | Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Global Overall Assessment of Postoperative Inflammation | The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear = improving satisfactorily = not improving or worsening | Day 15 |