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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 is a Phase 3 study that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 901 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03616899
The ClinicalTrials.gov registry entry for NCT03616899 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 901 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kala Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03616899 reports 0 study locations.
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.
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