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

Primary Purpose

Ocular Inflammation

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

KPI-121 1%

Prednisolone acetate

About this trial

This is an interventional treatment trial for Ocular Inflammation

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Byers Eye Institute at Stanford University
Children's Eye Care, PC
Pediatric Ophthalmology of Erie, Inc.
Houston Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KPI-121 1% BID (twice daily)

Prednisolone acetate QID (four times daily)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03596723

First Posted

July 12, 2018

Last Updated

September 21, 2020

Sponsor

Kala Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03596723

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

September 28, 2018 (Actual)

Study Completion Date

October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kala Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KPI-121 1% BID (twice daily)

Arm Type

Experimental

Arm Title

Prednisolone acetate QID (four times daily)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

KPI-121 1%

Intervention Description

eye drops

Intervention Type

Drug

Intervention Name(s)

Prednisolone acetate

Other Intervention Name(s)

Pred Forte

Intervention Description

eye drops

Primary Outcome Measure Information:

Title

Anterior Chamber Cell Grade

Description

Time Frame

Day 15

Secondary Outcome Measure Information:

Title

Modified Global Overall Assessment of Postoperative Inflammation

Description

Time Frame

Day 15

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Byers Eye Institute at Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94303

Country

United States

Facility Name

Children's Eye Care, PC

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Pediatric Ophthalmology of Erie, Inc.

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16501

Country

United States

Facility Name

Houston Eye Associates

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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