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NCT03846453 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
A Phase 3 study, sponsored by HanAll BioPharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT03846453: Completed Phase 3 study, sponsored by HanAll BioPharma Co..
NCT03846453 is a Phase 3 study that has completed, run by HanAll BioPharma Co.. The registered enrollment target is 637 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
NCT03846453, a Phase 3 study, has completed, sponsored by HanAll BioPharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
Study Summary
The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Primary Outcome
It was evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL HL036 Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2019-03-10 |
| Est. Completion | 2019-11-22 |
| Phase | Phase 3 |
What the finished NCT03846453 record still lists
NCT03846453 is an interventional study that assigns participants to a tested intervention. The registered 637 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.
NCT03846453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03846453 about?
NCT03846453 is a clinical study titled "A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes". The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
What is the current status of trial NCT03846453?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2019-03-10. Estimated completion is 2019-11-22.
What interventions are being tested in trial NCT03846453?
The interventions under investigation include: Placebo (BIOLOGICAL), HL036 Ophthalmic Solution (BIOLOGICAL).
Who is sponsoring clinical trial NCT03846453?
This trial is sponsored by HanAll BioPharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03846453's enrollment target sits among peer trials
637 579th of 2000 higher than 1,422 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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