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

Ocular Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03596723
• Other study ID #: KPI-121-C-010
• Status: Terminated
• Phase: Phase 3
• Start date: July 3, 2018
• Est. completion date: October 18, 2018

Study information

• Verified date: September 2020
• Source: Kala Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 18, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Ocular Inflammation

Intervention

Drug:
• KPI-121 1%
eye drops
• Prednisolone acetate
eye drops

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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