At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 901 enrolled
Drug / intervention
KPI-121 Ophthalmic Suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)
In Brief
A Phase 3 clinical trial evaluating KPI-121 Ophthalmic Suspension and Vehicle for Kerato Conjunctivitis Sicca. Completed, enrolled 901 participants across 81 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--
ConditionsKerato Conjunctivitis Sicca
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
First PostedAug 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedAug 6, 2018
Enrollment StartJul 10, 2018
Primary CompletionFeb 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.9 years ago
Interventions
KPI-121 Ophthalmic Suspensiondrug
KPI-121 Ophthalmic Suspension
Vehicledrug
Vehicle for KPI-121 0.25% ophthalmic suspension