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Safety and Efficacy of KPI-121 in Subjects With DED

NCT03616899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 901

Last updated 2021-04-02

Study results available
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Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Conditions

  • Kerato Conjunctivitis Sicca

Interventions

DRUG

KPI-121 Ophthalmic Suspension

KPI-121 Ophthalmic Suspension

DRUG

Vehicle

Vehicle for KPI-121 0.25% ophthalmic suspension

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
2018-07-10
Primary Completion
2020-02-05
Completion
2020-02-05
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 NCT03616899 on ClinicalTrials.gov