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

• Status: Terminated
• Trial end date: 2018-10-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kala Pharmaceuticals, Inc.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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