KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
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ClinicalTrials.gov Identifier: NCT03596723
Recruitment Status :
(NDA #210565 did not trigger the need for a Pediatric Research Equity Act/PREA study.)
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Start Date :
July 3, 2018
Actual Primary Completion Date :
September 28, 2018
Actual Study Completion Date :
October 18, 2018
Resource links provided by the National Library of Medicine
Anterior chamber cell grade [ Time Frame: Day 15 ]
Anterior chamber cell grade = 0. Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. The anterior chamber cell grading is whole numbers from 0 (no cells) to 4 (> 30 cells). Higher values indicate greater inflammation.
Secondary Outcome Measures :
Modified Global Overall Assessment of Postoperative Inflammation [ Time Frame: Day 15 ]
Modified Global Overall Assessment of Postoperative Inflammation score = 0. The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. The Modified Global Assessment grading is whole numbers from 0 (clear) to 3 (not improving or worsening). Lower values indicate greater healing.
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Layout table for eligibility information
Ages Eligible for Study:
up to 3 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Be a candidate for routine, uncomplicated cataract surgery
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 rise or elevated IOP