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NCT02163824 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
A Phase 3 study, sponsored by Kala Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
NCT02163824: Completed Phase 3 study, sponsored by Kala Pharmaceuticals.
NCT02163824 is a Phase 3 study that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 380 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02163824, a Phase 3 study, has completed, sponsored by Kala Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.
Primary Outcome
Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. 0= No cells seen 1. 1 to 5 cells 2. 6 to 15 cells 3. 16 to 30 cells 4. greater than 30 cells
Interventions
- DRUG KPI-121 0.25%
- DRUG KPI-121 1.0%
- DRUG Vehicle of KPI-121 0.25%
- DRUG Vehicle of KPI-121 1.0%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT02163824 record still lists
NCT02163824 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 4 interventions - of which KPI-121 0.25% is the first listed.
NCT02163824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02163824 about?
NCT02163824 is a clinical study titled "Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation". The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed...
What is the current status of trial NCT02163824?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2014-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02163824?
The interventions under investigation include: KPI-121 0.25% (DRUG), KPI-121 1.0% (DRUG), Vehicle of KPI-121 0.25% (DRUG), Vehicle of KPI-121 1.0% (DRUG).
Who is sponsoring clinical trial NCT02163824?
This trial is sponsored by Kala Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02163824's enrollment target sits among peer trials
380 983rd of 2000 higher than 1,014 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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