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

Phase 3

Terminated

• Conditions: Ocular Inflammation
• Interventions: Drug: Prednisolone acetate; Drug: KPI-121 1%

• Registration Number: NCT03596723
• Lead Sponsor: Kala Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-03
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Primary Completion: 2018-09-28
• Study Completion: 2018-10-18
• Results First Submitted: 2020-02-26
• Results First Submitted QC: 2020-04-06
• Results First Posted: 2020-04-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone acetate QID (four times daily)	Prednisolone acetate	-
KPI-121 1% BID (twice daily)	KPI-121 1%	-

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell Grade	Day 15	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

Secondary Outcome Measures

Name	Time	Method
Modified Global Overall Assessment of Postoperative Inflammation	Day 15	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; 1. = improving satisfactorily; 2. = not improving or worsening

Trial Locations

Locations (4)

Children's Eye Care, PC; 🇺🇸 Detroit, Michigan, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

Houston Eye Associates; 🇺🇸 The Woodlands, Texas, United States

Pediatric Ophthalmology of Erie, Inc.; 🇺🇸 Erie, Pennsylvania, United States