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

NCT03596723 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-10-19

Study results available
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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

Interventions

DRUG

KPI-121 1%

eye drops

DRUG

Prednisolone acetate

eye drops

Sponsors & Collaborators

  • Kala Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2018-09-28
Completion
2018-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596723 on ClinicalTrials.gov