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NCT03616899 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of KPI-121 in Subjects With DED
A Phase 3 study, sponsored by Kala Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 901
- Enrollment target
NCT03616899: Completed Phase 3 study, sponsored by Kala Pharmaceuticals.
NCT03616899 is a Phase 3 study that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 901 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616899, a Phase 3 study, has completed, sponsored by Kala Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 901 participants
- Enrollment target
Study 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).
Primary Outcome
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Interventions
- DRUG Vehicle
- DRUG KPI-121 Ophthalmic Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2020-02-05 |
| Phase | Phase 3 |
What the finished NCT03616899 record still lists
NCT03616899 is an interventional study that assigns participants to a tested intervention. The registered 901 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03616899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03616899 about?
NCT03616899 is a clinical study titled "Safety and Efficacy of KPI-121 in Subjects With DED". 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 ...
What is the current status of trial NCT03616899?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 901 participants. The study started on 2018-07-10. Estimated completion is 2020-02-05.
What interventions are being tested in trial NCT03616899?
The interventions under investigation include: Vehicle (DRUG), KPI-121 Ophthalmic Suspension (DRUG).
Who is sponsoring clinical trial NCT03616899?
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 NCT03616899's enrollment target sits among peer trials
901 349th of 2000 higher than 1,651 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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