CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 909 enrolled
Drug / intervention
KPI-121 0.25% Ophthalmic Suspension +1 moredrug
Likely dose
KPI-121 0.25% ophthalmic suspension, instilled as eye dropsAI-extracted
Key inclusion· 1
  • ✓Documented clinical diagnosis of dry eye disease in both eyes
Key exclusion· 5
  • ✕Known hypersensitivity or contraindication to KPI-121 or its components
  • ✕History of glaucoma or intraocular pressure >21 mmHg at screening/randomization, or current glaucoma treatment
  • ✕Ongoing ocular infection or severe ocular condition that could confound study assessments or limit compliance
  • ✕Exposure to investigational drug within 30 days prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02819284
NCT02819284Phase 3Completed
CompareCT.gov

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

Kala Pharmaceuticals, Inc.·interventional·Posted Jun 30, 2016·Updated Jan 5, 2021

In Brief

A Phase 3 clinical trial evaluating KPI-121 0.25% Ophthalmic Suspension and Vehicle of KPI-121 0.25% Ophthalmic Suspension for Dry Eye Syndromes and Keratoconjunctivitis Sicca. Completed, enrolled 909 participants across 62 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes, Keratoconjunctivitis Sicca
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartJun 1, 2016
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

KPI-121 0.25% Ophthalmic Suspensiondrug

Vehicle of KPI-121 0.25% Ophthalmic Suspensiondrug