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Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

NCT02813265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 918

Last updated 2021-02-03

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

  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca

Interventions

DRUG

KPI-121 0.25% Ophthalmic Suspension

DRUG

Vehicle of 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
2016-06-30
Primary Completion
2017-10-31
Completion
2017-10-31

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 NCT02813265 on ClinicalTrials.gov