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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: Completed Phase 3 study, sponsored by Kala Pharmaceuticals.
NCT02813265 is a Phase 3 study that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 918 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
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 |
What the finished NCT02813265 record still lists
NCT02813265 is an interventional study that assigns participants to a tested intervention. The registered 918 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 (19% higher).
The record links to 0 conditions, and to 2 interventions - of which KPI-121 0.25% Ophthalmic Suspension is the first listed.
NCT02813265 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02813265's enrollment target sits among peer trials
918 347th of 2000 higher than 1,654 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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