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

NCT03596723 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: KPI-121-C-010
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

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.

Conditions

Ocular Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Modified Global Overall Assessment of Postoperative Inflammation

  Day 15

Study Arms (2)

KPI-121 1% BID (twice daily)

EXPERIMENTAL

Drug: KPI-121 1%

Prednisolone acetate QID (four times daily)

ACTIVE COMPARATOR

Drug: Prednisolone acetate

Interventions

KPI-121 1% DRUG

eye drops

KPI-121 1% BID (twice daily)

Prednisolone acetate DRUG

eye drops

Also known as: Pred Forte

Prednisolone acetate QID (four times daily)

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (4)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

Children's Eye Care, PC

Detroit, Michigan, 48201, United States

Location

Pediatric Ophthalmology of Erie, Inc.

Erie, Pennsylvania, 16501, United States

Location

Houston Eye Associates

The Woodlands, Texas, 77380, United States

Location

MeSH Terms

Interventions

prednisolone acetate

Limitations and Caveats

Due to stopping the study after just two subjects were enrolled, no meaningful conclusions could be reached.

Results Point of Contact

• Title: VP Clinical Development
• Organization: Kala Pharmaceuticals, Inc

Results010@kalarx.com

781-996-5252

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: July 3, 2018
• Primary Completion: September 28, 2018
• Study Completion: October 18, 2018
• Last Updated: October 19, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)