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Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

NCT02793817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2020-12-16

Study results available
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Summary

The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

Conditions

  • Post Surgical Ocular Inflammation and Pain

Interventions

DRUG

KPI-121 1% Ophthalmic Suspension dosed BID

DRUG

Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Sponsors & Collaborators

  • Kala Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT02793817 on ClinicalTrials.gov