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

Stopped early · Phase 3

Conditions studied: Ocular Inflammation

In brief

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.

Key facts

Study ID

NCT03596723

Run by

Kala Pharmaceuticals, Inc.

People needed

2

Starts

2018-07-03

Expected to finish

2018-10-18

Last updated by the study team

2020-10-19

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be a candidate for routine, uncomplicated cataract surgery

You may not qualify if…

• 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

Where it is running

• Byers Eye Institute at Stanford University — Palo Alto, California, United States
• Children's Eye Care, PC — Detroit, Michigan, United States
• Pediatric Ophthalmology of Erie, Inc. — Erie, Pennsylvania, United States
• Houston Eye Associates — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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