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NCT02813265 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
A Phase 3 study, sponsored by Kala Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 918
- Enrollment target
NCT02813265 is a Phase 3 study that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 918 participants.
The verdict
NCT02813265, a Phase 3 study, has completed, sponsored by Kala Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 918 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 KPI-121 0.25% Ophthalmic Suspension
- DRUG Vehicle of KPI-121 0.25% Ophthalmic Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 918 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02813265
The ClinicalTrials.gov registry entry for NCT02813265 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 918 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 KPI-121 0.25% Ophthalmic Suspension is the first listed.
NCT02813265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02813265 about?
NCT02813265 is a clinical study titled "Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease". 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 NCT02813265?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 918 participants. The study started on 2016-06. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02813265?
The interventions under investigation include: KPI-121 0.25% Ophthalmic Suspension (DRUG), Vehicle of KPI-121 0.25% Ophthalmic Suspension (DRUG).
Who is sponsoring clinical trial NCT02813265?
This trial is sponsored by Kala Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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