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NCT05403827 · ClinicalTrials.gov registry record · Phase 3
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
A Phase 3 study, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
NCT05403827: Completed Phase 3 study, sponsored by Kowa Research Institute.
NCT05403827 is a Phase 3 study that has completed, run by Kowa Research Institute. The registered enrollment target is 644 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05403827, a Phase 3 study, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
Primary Outcome
* Eye Dryness Score (EDS) on Visual analog scale (VAS) * Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".
Interventions
- DRUG Placebo
- DRUG K-161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2022-07-03 |
| Est. Completion | 2023-12-05 |
| Phase | Phase 3 |
What the finished NCT05403827 record still lists
NCT05403827 is an interventional study that assigns participants to a tested intervention. The registered 644 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 (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05403827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05403827 about?
NCT05403827 is a clinical study titled "A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease". The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
What is the current status of trial NCT05403827?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2022-07-03. Estimated completion is 2023-12-05.
What interventions are being tested in trial NCT05403827?
The interventions under investigation include: Placebo (DRUG), K-161 (DRUG).
Who is sponsoring clinical trial NCT05403827?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05403827's enrollment target sits among peer trials
644 572nd of 2000 higher than 1,428 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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