NCT03596723

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

Terminated Phase 3 Results posted Last updated 19 October 2020

What this trial tests

Phase 3 trial testing KPI-121 1% in Ocular Inflammation in 2 participants. Terminated before completion.

Timeline

3 July 2018

Primary endpoint
28 September 2018

18 October 2018

Quick facts

Lead sponsor	Kala Pharmaceuticals, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	3 July 2018
Primary completion	28 September 2018
Estimated completion	18 October 2018
Sites	4 locations across United States

Drugs / interventions tested

• KPI-121 1% — full drug profile →
• Prednisolone acetate — full drug profile →

Conditions studied

• Ocular Inflammation — all drugs for Ocular Inflammation →

Sponsor

Kala Pharmaceuticals, Inc. — full company profile →

Who can join

Under 3, any sex, with Ocular Inflammation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anterior Chamber Cell Grade Primary · 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

Group	Value	95% CI
KPI-121 1% BID	0
Prednisolone Acetate QID	0
KPI-121 1% BID	1
Prednisolone Acetate QID	1
KPI-121 1% BID	0
Prednisolone Acetate QID	0
KPI-121 1% BID	0
Prednisolone Acetate QID	0

Modified Global Overall Assessment of Postoperative Inflammation Secondary · 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

Group	Value	95% CI
KPI-121 1% BID	0
Prednisolone Acetate QID	0
KPI-121 1% BID	1
Prednisolone Acetate QID	1
KPI-121 1% BID	0
Prednisolone Acetate QID	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

KPI-121 1% BID

Serious: 0/1 (0%)

Deaths: 0/1

Prednisolone Acetate QID

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (3 terms — click to expand)

Reaction	System	KPI-121 1% BID	Prednisolone Acetate QID
Suture Related Complication	Eye disorders	—	—
Increased Ocular Inflammation	Eye disorders	—	—
Otitis Media	Ear and labyrinth disorders	—	—

Data from ClinicalTrials.gov NCT03596723 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.