drugset / Trial / NCT03846453
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2019-03-10
- Primary completion
- 2019-11-22
- Completion
- 2019-11-22
Outcome
Missed primary endpoint
registry analysis (superiority test); 0.25% HL036 Ophthalmic Solution vs Placebo; p = 0.1871; NCT03846453 ↗
registry analysis (superiority test); 0.25% HL036 Ophthalmic Solution vs Placebo; p = 0.5549; NCT03846453 ↗
release “HL036 could not be verified through the ICSS(inferior corneal staining score), which was set as the primary endpoint” hanall.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HL036 | Unknown | 0.25 % | Topical |