At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 520 enrolled
Drug / intervention
KPI-121 1% Ophthalmic Suspension dosed BID +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 to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
In Brief
A Phase 3 clinical trial evaluating KPI-121 1% Ophthalmic Suspension dosed BID and Vehicle of KPI-121 Ophthalmic Suspension dosed BID for Post Surgical Ocular Inflammation and Pain. Completed, enrolled 520 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionMar 2017
TodayJul 2026
First PostedJun 8, 2016
Enrollment StartJun 1, 2016
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.1 years ago
Interventions
KPI-121 1% Ophthalmic Suspension dosed BIDdrug
Vehicle of KPI-121 Ophthalmic Suspension dosed BIDdrug